Quality Engineer – ISO 9001/13485 & CAPA Champion

FCX Performance; Newark (CA); On-site; USD 95,000 - 115,000; Full time

Job summary

Bay Advanced Technologies in Newark, CA is seeking a Quality Engineer to support the QMS for ISO 9001 and ISO 13485, focusing on product quality, supplier and customer issues, and audits. You will drive CAPA/8D processes and continuous improvements, and address RoHS, TSCA, REACH and PFAS data requirements.

Requirements include a BS in Mechanical, Electrical or Materials Engineering and 2–5 years in Manufacturing Quality.

Qualifications

• Self-starter and driven and ability to work independently.
• Knowledge of ISO 9001/13485 Quality Management Systems and practices.
• Knowledge of Engineering practices and procedures.
• Ability to effectively communicate – both verbal and written.
• The ability to multi-task and handle difficult situations professionally.
• Good interpersonal skills, motivation drive and initiative.
• Familiarity with mechanical CAD software programs a plus.
• Must be a team player and dependable.
• Strong computer skills, with knowledge of Windows, Outlook, Internet Explorer, and Excel.
• Experience with ERP (P21), PLM systems are desirable.
• Ability to understand mechanical drawings for pneumatic and electronic control sub-systems.
• Ability to map manufacturing and test processes to identify gaps causing product quality non-conformances.
• Ability to set SMART goals and execute on a timely basis.
• Perform other duties as required.
• Knowledge of PFMEA and DFMEA desirable.

Responsibilities

• Perform root cause analysis for customer CAPA reports and implement internal corrective actions and submit CAPA reports to customers.
• Perform supplier QMS/process audits and for product manufacturing controls as needed.
• Work with suppliers to resolve product quality issues on components/products. Issue CARs to suppliers and drive closures for product quality issues.
• Support QMS document updates for Newark, Singapore and Austin sites.
• Support QMS internal audits for Newark, Singapore and Austin.
• Support customer QMS and process audits.
• Update documents in the Document Control and Quality Management Systems for Bay sites.
• Weekly/monthly review of the RMA failure analysis data and WQDR reports with production for defect reduction.
• Support MRB activities and participate in MRB decision making as required.
• Work closely with Engineering to implement needed product engineering documents’ updates for quality improvement.
• Supervise FAI submissions for Bay customers.
• Perform other duties pertaining to quality as assigned.

Skills

Self-starter

ISO 9001/13485 knowledge

Engineering practices

Communication skills

Multitasking

Interpersonal skills

CAD familiarity

MS Office (Excel)

ERP (P21)

PLM systems

Reading mechanical drawings

Process mapping

PFMEA/DFMEA

Education

BS in Mechanical, Electrical, Materials Engineering

Tools

P21 ERP

PLM systems

Job description

Bay Advanced Technologies in Newark, CA is seeking a Quality Engineer to support the QMS for ISO 9001 and ISO 13485, focusing on product quality, supplier and customer issues, and audits. You will drive CAPA/8D processes and continuous improvements, and address RoHS, TSCA, REACH and PFAS data requirements.

Requirements include a BS in Mechanical, Electrical or Materials Engineering and 2–5 years in Manufacturing Quality.