Quality Engineer

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Corporate QA/RA Full Time Regular Professional Geneva, IL, US

2 days ago Requisition

Salary Range: $80,000.00 To $85,000.00 Annually

Bravida means Brav = Brave and Vida = Life

We are focused on patient lives and the bravery shown in care, recovery, service, healing, advocacy and everyday moments of resilience.

The Quality Engineer is a part of a Medical Device Manufacturing Quality team and will be responsible for supporting the Quality Management System and providing quality engineering services in support of medical device design, development, production and post-market surveillance activities. This position reports to the Quality Manager.

Strong process development capabilities as well as strong communication skills are essential.

• Support a sophisticated analytical lab for the testing, verification and validation of incoming raw substrate and gray fabrics, intermediate and final products. Laboratory processes include but are not limited to:
  • Atomic Absorption testing
  • Titration and pH
  • Microbiological testing (water quality, microbiological growth)
  • Mechanical testing (force, dimensional, pull, weight)
  • Chemical testing
  • Environmental Monitoring (Particulate, Microbiological)
• Creating and maintaining SOPs, Validation and Quality Control Plans as required; identify training needs and periodically review training effectiveness of employees.
• Creating, maintaining, and verifying a robust training system
• Creating new and maintaining existing supplier files.
• Support the QA, Manufacturing/Operations activities to produce consistent quality of products under applicable quality standards including monthly, quarterly, and annual testing requirements.
• Help develop and be the team member of cross-functional teams to create new products, processes and test methods.
• Assist with the development of medical device products from concept through development, testing and manufacturing scale-up.
• Create and implement inspection acceptance criteria and sampling plans to support production acceptance activity.
• Support equipment, product, and software Validation (IQ, OQ, PQ, TMV)
• Maintain the Device Master Record (DMR) per product.
• Support and create customer complaint record and assist with the investigation of customer complaints.
• Provide support on microbiological, chemical and physical capability studies.
• Serve as a member on the Material Review Board (MRB) to disposition non-conforming material.
• Generate corrective and preventative actions (CAPA and SCAR) and process owner of follow-up audits to facilitate close-out activities.
• Apply statistical problem-solving methods using Minitab.
• Adhere to general safety rules, company policies and procedures.
• Create and maintain production and QMS matrixes for management review of quality measurables.
• Participate in eQMS activities as required.

• Bachelor’s degree in Engineering, Microbiology, Chemistry, or equivalent work experience (5 years of relevant experience).
• Minimum of 1 year experience in Microbiology, Chemistry, or as a Quality Engineer, or higher educational levels, or 3 years as a Quality Technician.
• Experience functioning in a highly regulated environment such as medical devices, food, pharmaceuticals, automotive, or aerospace.
• Basic statistics experience with Probability and Descriptive statistics.
• Process development capabilities skills; analytical problem solving.
• Six Sigma and Lean Process background.
• Experience working in a Clean Room.
• Manufacturing experience.
• Metrology and Measurement Method Analysis experience.
• Must be able to travel up to 5% of the time.
• Typical work-related travel assignments range from 3-5 days, and as such overnight, out-of-town stays are required.

• Typical office environment – accommodations will be evaluated where needed.

Bioderm is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer,…