Bedford, United States
6 months ago
- Providing support to QA/QC, R&D, Manufacturing departments to ensure products are developed, manufactured, delivered, and serviced in compliance with regulations and customer needs
- Developing Quality Plans for inspection and test of incoming parts, components, assemblies, systems, products.
- Developing methods for Quality process control measurements and inspections
- Working with R&D to manage, gather, assemble, author and audit for accuracy and completeness of documentation throughout NPI / product lifecycle
- Providing leadership in product Risk Management
- Assessing and monitoring supplier controls
- Monitoring process performance and process capabilities, gather relevant data, identify quality trends, produce statistical reports and summarize findings for review and action
- Performing, monitoring, analyzing and reporting inspection/testing results and quality data, metrics, and trending.
- Developing and implementing SPC programs
- CAPAs, complaints, vigilance monitoring, investigations and procedure writing
- Minimum 3 – 5 years of Quality experience in the life sciences industry preferably with medical devices and or in
- bioprocess equipment and methods.
- Working knowledge of manufacturing processes, including but not limited to the manufacture of complex
- electro-mechanical equipment, capital equipment for Medical, Industrial and semiconductor industry.
- Experience in hardware, software, product development, verification, and validation
- Experience with six sigma, lean
- Good communication and technical writing skills
- Ability to thrive in a dynamic small / startup environment
- Experience with mechanical, electrical inspection
- Strong working knowledge with electrical and mechanical test equipment: Height gage, micrometer, dial indicators, gauges, mechanical and electrical measuring equipment, calipers, optical comparator, oscilloscope
• BS/BA in Sciences or Technical Discipline preferred