SUMMARY OF POSITION:

This position is onsite in Fremont, CA. The Sr Quality Engineer maintains Bay Material’s Quality activities related to operations, quality controls activities, supplier quality management and participating to investigation ensuring company procedures, regulatory and ISO requirements.

MINIMUM QUALIFICATIONS:

• Bachelor’s degree in engineering, material science, chemistry, and/or manufacturing
• 5+ years quality engineering experience in certified quality engineering, quality assurance, or a related role in a regulated industry (e.g., medical devices, pharmaceuticals, biotechnology, or manufacturing).
• 5+ years’ experience producing technical documents, such as quality plans, KPls at defined timeline, risk management in NCR and PFMEA for the quality system and formal procedures and/or work instruction
• 5+ years’ experience with ISO standards (e.g., ISO 9001, ISO 13485) and FDA regulatory guidelines (e.g., 21 CFR Part 820, 21 CFR Part 211)

PREFERRED QUALIFICATIONS:

• Master’s degree in engineering, material science, chemistry, and/or manufacturing
• Experience in leading supplier audits, nonconformance investigations, and corrective/preventive actions (CAPA)
• Strong work ethic, self-motivation and problem-solving skills
• Ability to work independently and in cross-functional teams with strong customer focus
• Ability to utilize Microsoft Office (Access, Excel, Word, PowerPoint) particularly Excel where advanced skills are a plus (Excellent Microsoft Excel skills are required)
• Familiarity with US and International medical device regulations
• Ability to utilize the basic quality tools including RCA, Fishbone analysis, SPCs, checklists, histograms, Pareto, scatter diagrams, process mapping and flow charts
• Statistical analysis such as SPC and data monitoring skills
• Support and assist other departments for investigations and collecting metrics
• Six Sigma/Lean Manufacturing skills
• APQP / PFMEA / Control plans experience

ESSENTIAL FUNCTIONS AND DUTIES:

• Manage non-conformances, including conducting root cause analysis, implementing corrective and preventive actions (CAPA), and ensuring proper resolution and documentation.
• Lead continuous improvement initiatives by automating measurement techniques, simplifying SPC requirements, clarifying work instructions, and evaluating processes for efficiency.
• Support validation and qualification efforts internally and with suppliers as defined in the Validation Master Plan, including equipment qualification, process validation, PFMEAs, and risk assessments, while maintaining comprehensive documentation.
• Facilitate technology transfer activities with suppliers by developing quality plans, sampling plans, process controls, and test methods to ensure smooth production transitions with accurate documentation.
• Perform statistical analyses such as process capability studies, GRR (Gage Repeatability and Reproducibility), DOE (Design of Experiments), and risk analysis to control processes and reduce quality costs.
• Participate in and support Design and Process FMEA (Failure Modes and Effects Analysis) activities, including updating risk management files and implementing mitigation strategies.
• Provide manufacturing support by troubleshooting production issues, analyzing defects, developing inspection methods, and overseeing calibration, verification, and maintenance of measuring equipment.
• Collaborate with QC Inspectors to select and manage appropriate metrology equipment for production needs.
• Manage document control processes, including the creation and maintenance of engineering change orders (ECOs), work instructions, and other quality system documentation to ensure compliance with QSR and ISO standards.
• Maintain ongoing compliance through process optimization, re-validation activities, and accurate record-keeping in alignment with internal policies and industry regulations.
• Lead and participate in cross-functional teams, validation projects, and quality reviews to meet organizational goals and drive quality initiatives.
• Manage and improve key quality metrics, support CAPA processes for production-related issues, and identify opportunities for process optimization.
• Contribute to departmental goals and objectives by collaborating with internal and external stakeholders to achieve continuous improvement.

NON-ESSENTIAL FUNCTIONS AND DUTIES:

• Attends Quality and other meetings as required.
• Participates in additional training relevant to this position.
• Other duties may be assigned, directed or requested.