Quality Engineer

9011 Bay Advanced Technologies LLC•Newark, CA

8d•$95,000 - $115,000•Onsite

About The Position

Bay Advanced Technologies, an Applied Fluid Power subsidiary, is seeking a Quality Engineer in Newark, CA. This role supports the Quality Management System (QMS) for ISO9001 and ISO13485 based quality practices, focusing on product quality, supplier and customer issues, audits, and documentation. The Quality Engineer will follow QMS protocols for corrective and preventive actions, complete 8D CAPA reporting, and drive continuous improvements for products and processes. The role also involves submitting customer queries related to RoHS, TSCA, REACH, and PFAS requirements.

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 system and related protocols.
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.
Must be a team player and dependable.
Strong computer skills, with knowledge of Windows, Outlook, Internet Explorer, and Excel.
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.
BS in Mechanical, Electrical, Materials Engineering.
2 – 5 years of Manufacturing Quality/ISO 9001/13485 related work experience in relevant fields/industry.

Nice To Haves

Familiarity with mechanical CAD software programs a plus.
Experience with ERP (P21), PLM systems are desirable.
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 (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.