Careers

People are the engine that drive Stradis Healthcare. Their expertise, their passion, their out-of-the-box thinking give our company the unique makeup that is forging our superior positioning in the customized medical kits market.

 

And because our colleagues are so important to the success of Stradis, we‘ve created a work environment that is creative, collegial and conducive to problem solving. We rely on one another. Our work is shared by each of us, working together, moving forward, and bringing our individual strengths to bear on solutions for our customers.

 

Stradis is committed to our employees, and that commitment is unequivocal.

 

If your interest is peaked and you want to invest in a company who invests in you, send us your resume and tell us something about yourself. We’d like to talk with you and know your story. 

Quailty Manager - Waukegan

Position: Quality Assurance Manager

Location: Waukegan, IL

JOB SUMMARY:

Plans, coordinates, and directs Quality Assurance and Quality Control staff to ensure continuous production consistent with established standards by performing the following duties.

SUMMARY OF ESSENTIAL JOB FUNCTIONS:

  • Accomplishes quality assurance human resources objectives by recruiting, selecting, orienting, training, assigning, scheduling, coaching, counseling and disciplining employees; communicates job expectations; plans, monitors, appraises and reviews job contributors; enforces policies and procedures.
  • Develops and analyzes statistical data and specifications to determine current standards; establishes quality and reliability expectancy of raw materials, in process material and finished product. Implements inspection criteria and procedures. Directs inspectors engaged in inspections and testing activities to ensure continuing control over material, facilities, and products including final product release.
  • Achieves quality assurance operational objectives by generating, analyzing and presenting data for the purposes of risk assessment/mitigation and strategic planning. Prepares and completes action plans; implements production, productivity, quality and customer-service standards ensuring efficiency improvement; identifies and resolves problems in close collaboration with the operations team; participates, coordinates and completes audits including communication with the regulatory body. Determines system improvements and implements change.
  • Formulates and maintains quality control objectives complementary to corporate policies and goals.
  • Maintains and improves product quality by completing product, company, system, compliance and surveillance audits; investigates customer complaints; collaborates with other members of management to develop new product and engineering designs, and manufacturing and training methods.
  • Creates, implements and maintains Standard Operating Procedures (SOP’s).
  • Maintains the overall calibration program. Coordinates all outside calibration testing required for the quality assurance function.
  • Generates and presents trending KPI’s for management review meeting. Plays an active role as a mentor, leader and team member on quality management teams and initiatives within the organization.
  • Responsible for overseeing Label design, generation, procedures and overall control. Creates and designs artwork per regulations and customer requirements.
  • Writes validation protocols when applicable; reviews, analyzes data and writes (when applicable) final reports to validations.
  • Maintains and ensures proper training records for the Quality department employees. Designs and implements quality control training programs for key personnel in conjunction with managers.
  • Coordinates on going testing as per internal SOPs (e.g. environmental test functions, Ethylene Oxide Residual testing, cytotoxicity testing, component Bioburden testing, quarterly TOC, BET, Conductivity, and Bioburden special Gamma radiation testing).
  • Monitors and updates Device Listing and FDA registration.
  • Represent the company during customer and regulatory audits.
  • Enhances department and organization reputation by accepting ownership for accomplishing new and different requests; explores opportunities to add value to job accomplishments.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education and/or Experience

Must have a Bachelor’s degree or higher in related field (s) and a minimum of 3-5 years’ experience in quality management. Must possess excellent PC skills (MS Office, Outlook, Word, Excel, PowerPoint, Publisher, label software, Driver/printer installation, etc).

Language Skills

Must be able to speak, read and write in English. This position requires excellent verbal communication skills. Bilingual skills are a plus. Should possess excellent communications/interpersonal and organization skills.

Mathematical skills

Must be able to perform basic mathematical calculations including but not limited to addition, subtraction, multiplication, division, standard deviations, and averaging, metric and standard conversions as well some algebraic functions. Basic knowledge of geometric tolerencing and incoming inspection tools is beneficial.

Reasoning Ability

Requires ability to make sensible determinations when making company related decisions. This position requires the capability to do multitasking in a team environment that includes the ability to interface with all levels of management. This position requires a person with excellent strategic planning, and great focus on analyzing information and process improvement.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

DISCLAIMER

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Please send resume to jcrowder@stradishealthcare.com to apply!

Quality Manager - Norcross

Position: Quality Assurance Manger

Location: Norcross, GA

JOB SUMMARY:

The Quality Assurance Manager is responsible for planning, execution, and continuous improvement of the company quality system to assure compliance with US and International regulatory requirements. Individual is responsible for collaboration with all personnel regarding problem identification, root cause analysis, improvement/corrective action planning, and execution of improvements.

This position will directly interact with senior management and various teams on a routine basis and be the primary contact for internal and external contacts regarding regulatory affairs issues.

SUMMARY OF ESSENTIAL JOB FUNCTIONS:

  • Acts as the Management Representative for quality system.
  • Directly responsible for implementation and maintenance of the company quality system. The Quality Manager also has responsibility to act as liaison with external parties on matters relating to the quality and regulatory system.
  • Analyzes, evaluates, and presents information concerning factors such as manufacturing problems, customer complaints, non conformances, quality system, etc. for review by supervisor and/or other members of management team.
  • Assists supervisor in formulating and establishing company policies, operating procedures, and goals.
  • Assists supervisor in developing initial and subsequent modifications of product assurance program to delineate areas of responsibility, personnel requirements, and operational procedures within quality program.
  • Provides input for quality assurance budget.
  • Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures.
  • Confers with all departments regarding quality assurance issues of new and existing products to ensure compliance with the quality system.
  • Reviews technical publications, articles, and abstracts to stay abreast of technical developments in industry.
  • Prepares documentation and systems for compliance with ISO, FDA or other regulatory bodies.
  • Manage the submission process for US and international submissions including authoring and writing the submissions. These may include 510(k), Design Dossier, Technical Files, related documentation, and periodic reports.
  • Lead the change control board activities including documentation, work instruction, SOPs, change notices, and labeling changes; be the primary Regulatory Affairs contact to teams and individuals initiating these changes.
  • Participate in the product/service development process as applicable; define the regulatory pathway and requirements to ensure that materials meet company and regulatory requirements while maintaining competitive positioning.
  • Provide information on competitor’s regulatory activities. Evaluate and communicate the impact of competitor experience and current agency expectations and utilize this information in the creation and development of effective regulatory strategic and tactical options.
  • Responsible for full compliance to all FDA, CE, registered country, and ISO13485 requirements. Functions as the management representatives in all quality and regulatory matters and manages all document control functions. Manages all relationships necessary to maintain highest levels of integrity in compliance.
  • Manages all quality assurance testing for products and clean room, including biocompatibility, sterility assurance levels, shelf life, packaging, and product efficacy.
  • Creates, reports, and takes corrective action on a balanced scorecard of enterprise performance metrics.
  • Plans and conducts internal quality audits according to schedule and in compliance with regulatory requirements. Captures results and takes corrective action as necessary.
  • Collaborates to execute solutions with all departments regarding quality assurance issues.
  • Other duties as prescribed.

REQUIRED KNOWLEDGE AND ABILITIES: 

  • Knowledge of FDA’s Quality System Regulation, 21 CFR 820, ISO 13485, and Medical Device Directive (MDD 93/42/EEC).
  • Knowledge of Quality Management System
  • Knowledge of GMP
  • Knowledge of Microsoft Office, ERP systems, and other business software.
  • Excellent problem solving and analytical skills for continuous improvement
  • Ability to work as a positive and motivational partner to the enterprise
  • Excellent written and oral communication skills.
  • Lean and Six Sigma certification is a plus.

PHYSICAL REQUIREMENTS:

  • Must be physically able to operate a variety of automated office machines including computers, copiers, printers, facsimile machines, telephones, etc.
  • Must be able to work, move, or carry objects or materials such as files, computer printouts, reports, calculators, pencils, legal pads, etc.
  • May be required to lift moderate weight infrequently as a result of inspection, validation, or testing of products.

MINIMUM EDUCATION, TRAINING, AND/OR EXPERIENCE:

BS degree in a technical or management field that provides a solid background in quality and regulatory discipline, plus five years of experience leading quality management functions in a medical device company, or some equivalent combination.

Please email resume to jcrowder@stradishealthcare.com to apply!

Customer Service Representative – Waukegan

Position: Customer Service Representative

Location: Waukegan, IL

JOB SUMMARY:

Provides superior customer service to clients using critical thinking skills. Accurately performs follow up and resolution measures to resolve client inquiries. Performs all functions (Order Entry, Back-order research, Returns and Credit processing and daily phone inquiries) on the Customer Service team as needed and as instructed. Acts as primary client liaison.

SUMMARY OF ESSENTIAL JOB FUNCTIONS:

  • Understands and performs the following activities as needed: data/order entry, credit processing, customer outreach
  • Act as primary point of contact for incoming inquiries via phone and email in a professional and courteous manner.
  • Confirm orders with customers
  • Respond to customer requests regarding shipping and tracking of deliveries
  • Assist with Freight Claims for damaged product
  • Generate paperwork for customer Credit Memos
  • Communicate surfaced issues to the customer in order to address and resolve in a timely manner.
  • Create weekly customer reports, as required.
  • Maintain professional, accurate verbal and written communication with both internal and external Customers.
  • Works in an efficient manner with an eye towards problem solving.
  • Fully documents all work performed and communications with customer.
  • Uses case management software to appropriately record and track outstanding activities.
  • Establishes and maintains a strong, collaborative relationship with all teammates in order to meet Customer expectations and to communicate Customer concerns.
  • Provide superior service to clients.

SUPPLEMENTAL JOB FUNCTIONS:

Performs additional duties as directed.

Escalates issues to Sales, Management or Warehouse personnel as needed.

 

QUALIFICATIONS

EDUCATION & EXPERIENCE REQUIRED:

  • High School Diploma, General Education Degree (GED), or equivalent required
  • Associate or Bachelor’s Degree preferred
  • Two or more years of work experience in data entry and/or in a customer-service required
  • Knowledge of customer relationship management (CRM) software preferred

KNOWLEDGE SKILLS & ABILITIES:

  • Customer-focused and self-motivated problem solver who is comfortable with performing in a key role supporting our customers
  • Ability to use critical thinking skills in order to problem solve.
  • Ability to quickly learn and utilize enterprise software technologies like Enterprise Resource Planning (ERP) and Client Relationship Management (CRM) systems
  • Ability to work independently and as part of a team
  • Good recordkeeping skills, both soft and hard copies
  • Excellent telephone manner and customer service skills
  • Ability to be flexible, adaptable and organized in performing work processes
  • Ability to demonstrate initiative and independence, as appropriate
  • Ability to deal with difficult customers, deliver complex messages and build good working relationships
  • Strong knowledge of arithmetic, English and grammar
  • Strong attention to detail

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Please send resume to jcrowder@stradishealthcare.com to apply!

Production Supervisor - Waukegan

Position: Production Supervisor

Location: Waukegan, IL

FLSA Status: Exempt

1st and 2nd shift

JOB SUMMARY:

The purpose of this role is to perform the vital functions of coordinating and supervising production activities and closely follow production plan on a weekly and daily basis; coordinate and expedite workflow with-in and between departments based on priorities. Responsible for supporting the current manufacturing and facilitating the continuous improvement processes associated with the manufacturing methods and processes in the facility. Will work across departments with production, quality, material management and sales team members to improve operations and reduce cost.

ESSENTIAL DUTIES AND RESPONSIBILITIES, including but not limited to:

· Evaluates and recommend process and technology improvements to maximize workflow

· Inspects products to verify conformance to specifications and directs setup and adjustments of machines

· Coordinates work schedule for the shift and communicates with other supervisors for a smooth coordination between shifts and other departments

· Maintains productions records

· Reviews batch Records and assigns lot #s and expiration dates

· Ensure safety procedures are in place and being followed

· Understands of specific requirements for each production line and ability to manage workflow

· Determines production priorities by reviewing customer orders and requirements

· Updates and develop standard operating procedures

· Controls and monitor production on a daily basis

· Makes suggestions to improve processes in regard to quality and productivity

· Uses Lean and Six Sigma tools and methodologies to increase production efficiency

· Researches, analyzes and effectively consolidates production related information and presents for management review

· Formulates and presents document research, progress, and results to team and internal customers

· Conducts time studies for workforce production to establish standards and measure performance, hold team accountable to standard operating procedures

· Establishes programs of work measurement in order to guarantee fulfillment of targets and deadlines

· Develops current state and future state mapping to identify and improve processes

· Resolves production scheduling problems by analyzing reports; developing solutions

· Identifies and analyze data for accuracy and conformance to standards

· Requires problem-solving abilities, organizational skills and attention to detail. Ability to analyze data for accuracy and deductive reasoning is essential. Must have the capability to recognize inconsistencies and identify potential solutions.

QUALIFICATIONS/ SKILLS:

EDUCATION

Minimum 2 years of college education and 2 years supervisory experience in either medical device or pharmaceutical industry

Or Minimum 6 years supervisory in manufacturing/production

GENERAL SKILLS AND ATTRIBUTES

Strong interpersonal, communication and presentation skills

Strong analytical and organizational skills

Have a working knowledge of lean manufacturing, six sigma

Computer experience, working knowledge of Microsoft products including Office, Excel; ERP system

REASONING ABILITY

Requires expert problem-solving abilities, exceptional organizational skills and attention to detail

Ability to analyze data for accuracy and deductive reasoning is essential. Must have the capability to recognize inconsistencies and identify potential solutions

This position also requires multitasking in a team environment that includes the ability to interface with all levels of management

WORK ENVIRONMENT

Stradis Healthcare is built upon the principles of ethical conduct and as such has set forth the highest standards of behavior

Each and every department within the organization works closely together with respect and integrity

Stradis Healthcare provides a safe and healthful work environment for its employees

Please send resume to jcrowder@stradishealthcare.com to apply!