Job Title: Product Quality Specialist
As a member of the Product Quality Specialist team, you will provide QA support to Med-Eng’s Sensor Program(s), creating quality plans, monitoring Contract Manufacturer(s) performance, and assisting with planned inspection, customer acceptance, and product audit activities. You will also support other projects, in production and at Med-Eng suppliers, to ensure the timely supply of quality finished goods.
This position collaborates with Product Development, NPI, Manufacturing Engineering, Manufacturing Quality, and Supply Chain teams to establish control plans based on design and manufacturing requirements, monitor performance, and initiate corrective actions as needed, following Med-Eng processes and customer requirements.
Key Interactions
This role interacts with Med-Eng Suppliers, Customers, Quality Organization, Engineering, Procurement, Product Line, Manufacturing, and New Product Introduction (NPI) teams.
Duties & Responsibilities
- Provide product quality support to development projects, mid-life improvements, customer programs, and manufacturing, including:
- Quality planning
- Facilitating DFMEA / PFMEA
- Communicating acceptance criteria via inspection/test instructions, checklists, etc.
- Identifying inspection/test instrumentation requirements
- Ensuring product traceability
- Conducting First Article Tests and Inspections (FAT/FAI)
- Supporting Product Physical and Functional Configuration Audits (PCA/FCA)
- Evaluating processes
- Training suppliers and internal inspectors on Med-Eng products
- Performing product and process audits
- Analyzing inspection yield and performance data
- Following up on corrective actions and coordinating inspections with GQA or customer representatives
- Performing or coordinating off-site acceptance inspections and audits
- Investigating problems, performing root cause analysis, and implementing corrective actions
- Supporting internal and external manufacturing quality escalation
- Developing and reviewing quality documentation
- Contributing to Material Review Board (MRB) assessments and NCRs
- Providing technical guidance and maintaining quality records
Ensure compliance with corporate policies, processes, contractual, and regulatory requirements.Qualifications- Technical Certificate/diploma in mechanical, electronic, or equivalent discipline, or relevant experience
- Health and Safety training
- ASQ Certified Quality Engineer and/or Auditor preferred
- 5-10 years’ experience in a quality role within product development or manufacturing
- Knowledge of ISO 9001 standards
- Understanding of market product regulatory requirements (CE, NIJ, ULC, etc.)
- Strong problem-solving and data analysis skills (Lean, 6 Sigma, 8D, etc.)
- Experience with inspection, testing, and de-risking procedures (FAT, FMEA, PPAP, PCA, FCA)
- Ability to interpret technical documents and diagrams
- Strong organizational skills and ability to work independently
- Effective communication skills
- Ability to travel internationally and hold a valid driver’s license
Other duties may be assigned as needed by the PQ Team Lead, Director of Quality, or their designee.