Adecco is assisting a local client recruiting for Sr Quality Engineer opportunities in Fremont, CA. This is an excellent opportunity to join a winning culture and get your foot in provides advanced dental implants, prosthetics, CAD/CAM solutions, and regenerative products, supporting dentists and labs worldwide. If Sr Quality Engineer sounds like something you would be interested in, and you meet the qualifications listed below, apply now!
Job Summary
The Quality Engineer will maintain Bay Material's quality activities related to operations, quality control, supplier quality management, and investigations, ensuring compliance with company procedures, regulatory requirements, and ISO standards.
Duties and Responsibilities:
Manage non-conformances, conduct root cause analysis, and implement corrective and preventive actions (CAPA).
Drive continuous improvement initiatives by automating measurement techniques, simplifying SPC requirements, and optimizing processes.
Support validation and qualification efforts, including equipment qualification, process validation, PFMEA, and risk assessments.
Facilitate technology transfer with suppliers by developing quality plans, sampling plans, and process controls.
Perform statistical analyses (SPC, GRR, DOE) to control processes and reduce quality costs.
Participate in Design and Process FMEA activities and update risk management files.
Provide manufacturing support by troubleshooting production issues and developing inspection methods.
Collaborate with QC Inspectors to select and manage metrology equipment.
Manage document control processes, including ECOs and work instructions, ensuring compliance with QSR and ISO standards.
Maintain compliance through process optimization and accurate record-keeping.
Lead cross-functional teams and quality reviews to meet organizational goals.
Required Skill
Bachelor's degree in Engineering, Material Science, Chemistry, or Manufacturing.
5+ years of quality engineering experience in a regulated industry (medical devices, pharma, biotech, or manufacturing).
Strong knowledge of ISO standards (ISO 9001, ISO 13485) and FDA regulations (21 CFR Part 820, 21 CFR Part 211).
Experience producing technical documents, risk management, and quality plans.
Experience in supplier audits, nonconformance investigations, and CAPA.
Advanced Microsoft Excel skills; proficiency in MS Office Suite.
Familiarity with US and international medical device regulations.
Knowledge of quality tools (RCA, Fishbone, SPC, Pareto, process mapping).
Six Sigma/Lean Manufacturing skills; APQP/PFMEA/Control Plans experience.
What's in this Sr Quality Engineer position for you?