Quality Assurance Manager

Santa Clara, CA
Full Time

Position Summary:

Quality Management System (QMS)

    • Serve as the subject matter expert for the company on compliance issues. Provide guidance and support on matters relating to FDA/FBD/ISO regulations
    • Responsible for maintaining appropriate regulatory documents for REACH, RoHS, and Conflict Minerals requirements.
    • Coordinate ISO and customer audits. Coordinate FDB and/or FDA inspections if required.
    • Responsible for directing the Promex Document Control function. Ensure all ECNs are reviewed for QMS impact.

Quality Assurance Management

    • Manage Quality Engineers, Quality Assurance, and Quality Control activities
    • Maintain records for customer complaints, NCMR, RMA, deviations, and CAPA.
    • Work closely with Engineering and Operations to ensure that new processes being transferred to production meet customer and regulatory requirements.
    • Monitor and report Key Performance Indicators (KPI’s) related to company quality objectives.
    • Plan and manage the overall activities of receiving inspection and outgoing quality functions.
    • Ensure timely resolution of supplier failures, supplier corrective actions and preventive actions.

Quality Engineering Management

    • Manage the company’s risk management process to ensure the appropriate risk assessment is performed and documented.
    • In conjunction with process engineering, conduct root cause analysis and implementation of corrective action for process and customer related concerns.
    • Possesses or can obtain an IPC-A-610 and IPC-A-600 Certified IPC Trainer certificate.

Standardize inspection activities for package assembly operations using MIL-STD-883 internal and external visual requirements.

 

Minimum Qualifications:

    • Bachelor of Science degree in Engineering or related discipline
    • Qualified (Exemplar Global) ISO 9001 / 13485 Lead Auditor is a plus
    • 5 years’ experience in the medical products EMS industry.
    • 2 years of direct supervisory/manager experience
    • Proficiency in Microsoft Office Suite, Outlook email and database systems

 

Key Competencies:

    • Strong knowledge of Quality Management Systems (QMS); particularly ISO 9001 and ISO 13485, 21 CFR 820, ITAR
    • Considered a subject matter expert
    • Must be well-organized with strong problem-solving skills.
    • Excellent written and oral communication skills, solid organizational ability, negotiations skills with ability to drive cross functional teams.
    • Strong mechanical spec interpretation skills
    • Ability to define problems, collect data, establish facts, draw valid conclusions, and succinctly present data and information
    • High level of proficiency in document control protocols

 

Preferred Skills:

Prior experience working in a medical device contract manufacturing environment offering microelectronic assembly services