Manager of Quality Operations in West Menlo Park, CA at Volt

Date Posted: 3/17/2020

Job Snapshot

Job Description

Manager of Quality Operations-Direct Hire

Job Summary
The Manager of Quality Operations is responsible for analyzing, implementing, and executing processes to ensure product quality and compliance to the Quality System. This role is responsible for supporting strategic initiatives in support of business needs and medical device Quality System regulations.

Responsibilities
• Manage incoming and in-process quality control staff and activities
• Manage all departmental employee related activities (i.e., hires, trains, appraises, rewards, motivates, disciplines) as well as department budget
• Provide ongoing development, feedback, coaching, and mentoring to the staff.
• Manage the non-conforming materials program, including leading/supporting investigations.
• Review and approve equipment IQ, OQ, and PQs.
• Manage calibration program.
• Collaborate with Operations to close out audit findings or corrective actions.
• Lead or participate on project teams to improve/monitor manufacturing quality issues/performance, or component design improvement activities.
• Help specify and develop product acceptance criteria/test procedures for purchased subassemblies, components and final assemblies
• Develop, implement, and monitor various quality metrics. Identify opportunities for continuous improvement and customer satisfaction. Compile and represent data for monthly quality process review.
• Gather and analyze data for root cause analysis. Coordinate and drive efforts to assure non-conformance and/or corrective action activities are opened and completed appropriately. Work with Engineering and Manufacturing to develop and implement process corrective actions.
• Ensure compliance to regulatory requirements. Uphold quality system. Support internal and external audits.
• Work in a cross-functional team environment including members from Manufacturing, Clinical, Regulatory, and Marketing.

Qualifications
• BS degree in relevant scientific or quality discipline (Mechanical, Biomedical, or Materials Engineering preferred)
• CQE or CMQ/OE certification a plus
• Minimum 8 years’ experience in Medical Device industry; quality engineering, manufacturing or product development experience preferred
• Minimum 2 years supervisory experience
• Working knowledge of lean manufacturing, Six Sigma, Project Management principles a plus.
• Understanding and working experience with ISO14971,QSR, ISO13485, and regulatory approval methods.
• Knowledge of quality control process and statistical techniques.
• Understanding of manufacturing processes and techniques.
• Strong analytical and problem solving skills; strong attention to detail.
• Proficient with Excel (PivotTables, trending, charting).
• Excellent verbal and written communication skills.
• Strong interpersonal skills and the ability to work with cross-functional teams.

Volt is an Equal Opportunity Employer