Senior Quality Manufacturing Engineer

Stryker • San Jose, CA

120d • $100,400 - $160,800

About The Position

Stryker is hiring a Senior Quality Manufacturing Engineer in San Jose, CA, to enhance and sustain quality standards in repair processes for medical products. In this role you will focus on improving procedures, collaborating with suppliers, and supporting compliance with regulatory standards while driving cost and efficiency improvements.

Requirements

• Bachelor's Degree in a technical field.
• 2+ years of relevant full time experience.

Nice To Haves

• Bachelor's in Engineering.
• Knowledge of applicable domestic and international regulations and quality system standards - FDA QSR, MDD, ISO13485, ISO9001, etc.
• Experience with Non-Conformances and Corrective and Preventative Actions.
• Ability to express ideas and collaborate effectively with multidisciplinary teams.
• Experience in independently executing moderately complex problem-solving techniques related to manufacturing/design technical issues.
• Good instincts and sound judgement for mechanical and structural design.
• Solid analytical skills, ability to plan, organize and implement concurrent tasks.
• Demonstrated mechanical/electrical problem-solving skills.
• Proven ability to handle multiple assignments at once while meeting all deadlines.
• Must be able to routinely make decisions which affect immediate operations.
• Demonstrated ability to plan, track and facilitate projects.
• Understanding of Quality Management System tools, Six Sigma tools, problem solving, root cause analysis, Lean and continuous improvement methodologies, with proven ability to apply them.

Responsibilities

• Identify and lead implementation of procedure, process improvements of responsible repair lines.
• Communicate and collaborate with suppliers to solve product and component quality issues.
• Trend key quality metrics and proactively take action as needed.
• Independently review, trend, and process nonconformances for responsible product and components.
• Troubleshoot product quality issues of moderate complex scope where the analysis requires a variety of factors.
• Own NCs/CAPAs for responsible product and support overall team in implementation of robust corrective and preventative actions.
• Ensure compliance of documentation for inspection/testing and repair procedures.
• Train repair technicians on repair processes and procedure changes.
• Responsible for processing supplier-initiated requests and necessary supporting documentation.
• Partner with repair technicians and supervisors to ensure processes and equipment can meet demand requirements.
• Drive continuous improvement actions/initiatives with suppliers and in-house teams to reduce quality issues, increase performance, reduce lead time, reduce cost, etc.
• Execute moderately simple validation of equipment.
• Provide input in the new product development process by using current generation data to identify effective and efficient repair techniques.
• Support Service in internal and external audits (FDA and Notified Body auditors).
• May interact with customers to solve reliability issues and/or answer general product questions.

Benefits

• $100,400 - $160,800 salary plus bonus eligible + benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree