Quality Engineer I

The Quality Engineer reports directly to the Vice President of Quality & Regulatory Affairs 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.

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:
  1. Atomic Absorption testing
  2. Titration and pH
  3. Microbiological testing (water quality, microbiological growth)
  4. Mechanical testing (force, dimensional, pull, weight)
  5. Chemical testing
• Support in creating and maintaining SOPs, Validation and Quality Control Plans as required; identify training needs and periodically review training effectiveness of employees.
• 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.
• Provide engineering support for product quality.
• 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.
• Other projects as assigned by the management.

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.
• Higher educational background may suffice for experience in some of the above requirements.

Education

• Bachelor's degree in Engineering, Microbiology, Chemistry, or equivalent (5 years in relevant experience).

General Skills/Competencies/Specialized Knowledge

• Ability and motivation to work on own initiative.
• Strong written and verbal communication skills.
• 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.

Travel

• 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.

Work Environment and Physical Demands

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