Quality Engineer

Job Description

Job Description

Quality Engineer – Newark, CA

 

While we are looking to hire a mid-range Level II candidate, we are open to exploring Level I (provided there is relatable industry experience) and Level III candidates.

As the Quality Engineer, you will support the Quality Management System (QMS) for ISO9001 and ISO13485 based quality practices for product quality, supplier and customer quality issues, internal/external audits and documentation requirements. Follow QMS protocols for corrective and preventive actions to complete 8D CAPA reporting to customers and enhance product quality and implement continuous improvements for products and processes. Submits customer queries on products related to RoHS, TSCA, REACH and PFAS requirements.

Role Requirements:  

Excellent technical, computer, written and verbal communication skills. Ability to interact well and work independently with subordinate personnel to achieve company goals pertaining to quality in terms of meeting customer requirements and achieving customer satisfaction in a timely manner. Must be detail oriented and have good organizational skills. Requires a good understanding of document control systems and related protocols.

Position 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 our sites. Weekly/monthly review of the RMA failure analysis data and WQDR (in-line rejections due to assembly or OEM defects) reports with production for defect reduction to help improve final test yield and in-line 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.

Essential skills and experience:

· 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.

Minimum Qualifications:

· BS in Mechanical, Electrical, Materials Engineering.

· 2 – 5 years of Manufacturing Quality/ISO 9001/13485 related work experience in relevant fields/industry.