A biotech manufacturing company in Sunnyvale, CA is looking for a Quality Engineer – Supplier to be responsible for quality engineering activities focused on instrumentation hardware. Primary responsibilities will be to support New Product Development core teams through supplier quality engineering and quality engineering duties.
- Supports and/or creates Quality Engineering documentation such as Quality Plan, Validation Master Plans and Reports.
- Participates in development projects by providing quality engineering services to assigned projects. Ensure defendable engineering and scientific analyses are employed and design history files comply with company policies and governmental regulations.
- Provides project with guidance on sound design control strategy compliant with Quality System Regulations (QSR) and Quality Management Systems (QMS), supporting a product release that is safe and effective, meets intended use, and is sustainable in the field.
- Understands and applies the manufacturing quality toolset including NCR, SCAR, SRB, MRB, PFMEA, IQ, OQ, PQ, GR&R/measurement system analysis, control plans, process verification/validation plans, validation protocol development, Cpk, Cp, SPC, hard gauging applications, computer-based inspection methods, operator work instructions, DOE, process data analysis, and DMAIC.
- Reviews drawings to evaluate quality requirements including correct application of geometric dimensioning and tolerancing (GD&T), proper use of engineering, process and material specifications, and identification of key characteristics for inspection plans and methods. Recommend revisions to assure design requirements are specified in the appropriate detail and clarity to provide a successful design transfer.
- Attends and guides product risk assessments, ensuring effective hazard identification, appropriate risk controls identification, and appropriate documentation of risk assessments
- Works with product support teams, engineering and others on component quality issues and supplier initiatives.
- Attends meetings and work effectively with extended teams which may include Manufacturing, Engineering, Research and Development, Quality, Regulatory and Marketing.
- Summarizes and communicates progress and meeting outcomes to Quality Program Manager in a timely manner.
Bachelor’s Degree in mechanical engineering, electrical engineering, industrial engineering or related discipline and a minimum of 3 to 5 years related experience OR Master’s degree in mechanical engineering, electrical engineering, industrial engineering or related discipline and a minimum of 2 to 3 years related experience.
FDA regulated medical device product development environment experience.
Design control during product development.
Superior communication skills, both oral and written.
Working knowledge of statistics.
Strong background and experience in NPD Quality for instrumentation hardware qualification.
Ability to work effectively in a team environment and build strong working relationships.
Ability to constructively challenge concerns and engage in transparent conversations.
Strong attention to detail.
Ability to successfully balance and prioritize multiple on-going projects/tasks.
High degree of initiative and self-motivation.
Strong analytical and problem-solving skills.
- Knowledge of CFR 21 Part 820 (QSR), ISO 13485
- Experience in product mechanical evaluation & testing and GD&T
- Experience with Minitab or similar statistical software
- A quality engineering certification from the American Society for Quality (ASQ), or other qualifying organizations. Examples include the CQE, CRE, CQA.
- Experience in the application of production and process controls including process validation, process control plans and statistical process control.
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.