Business Unit: Point of Care
Requisition Number: 247822
Primary Location: United States-Indiana-Mishawaka
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: No
Manufacturing Quality Engineers are primarily responsible for all quality related aspects of the manufacturing processes within the plant. This includes day to day support of the manufacturing line, problems that occur, and non-conformance that may be generated. The role works closely with the manufacturing and engineering teams to assure compliance with all appropriate regulations and specifications. Prompt responsiveness is a requirement to avoid downtime.
- Support design transfer of new production coming into the facility, including validations, process controls, procedures, process monitoring, and other commissioning activities.
- Interact with multiple functions across sites including Engineering, Manufacturing, Technical Operations, and Regulatory Compliance.
- Become Subject Matter Experts on all aspects of each production line.
- Resolve production non-conformances, working through the MRB process.
- Write or revise necessary production-controlled documents as needed.
- Participate as a manufacturing Subject Matter Expert on any process change to assure that proper documentation, validations, and/or qualifications are performed.
- Responsible for assuring prompt completion of process related quality notifications and tracking/reporting all necessary tasks to assure completion.
- Participate in root cause investigations.
- Participate in CAPA Review Board as required
- Participate in Validation Review Board as required
- Prepare for FDA inspections and registrar audits
- Able to effectively communicate with internal and external customers
Required Knowledge/Skills, Education, and Experience:
- Preferred Bachelors Science – Mechanical Engineering. Also acceptable with equivalent experience: Other engineering or science degree.
· Seeking immunoassay experience with microfluidics, protein chemistry, and ELISA.
· 10 years’ experience in the medical device/pharmaceutical industry. Knowledgeable of all industry regulations and requirements.
· Process Control Technology experience is helpful.
· Statistical knowledge and Design of Experiments experience.
· Strong procedure development/technical writing skills.
· Value Stream Mapping/Lean experience is helpful.
· Strong communications background, both written and verbal.
· ASQC Certifications helpful.
Other characteristics of the successful candidate:
- Very organized, detail-oriented
- Highly self-motivated
- Able to work independently
- Excellent analytical, communication, writing, and problem-solving skills
- Effective and influential in his/her interactions in team-based assignments
· Able to work well with personnel from different departments, and experience levels
· Ability for potential international travel from time to time.