Quality Assurance Manager

Quality Assurance Manager:

Precision Measurements, Inc. is an ISO 9001:2015 Quality certified and ISO/IEC 17025:2017 ANSI/NCSL Z540-1-1994 (R2002) Accredited Metrology Laboratory located in San Jose, California – the heart of Silicon Valley. PMI has been providing quality metrology services for over 35 years for a wide range of Electronic, Analytical, Mechanical / Dimensional Measuring and Test Equipment. We specialize in the fields of biomedical, pharmaceutical, telecommunications, semiconductor and electronic manufacturing services for high technology markets, setting standards to provide the best value to our customers and growth opportunities to our employees.

Precision Measurements, Inc. was founded in 1984 with the mission to establish a vendor/customer partnership for a positive business relationship to ensure all of our customers’ requirements are met. Offering and providing customers with a better source for Service, Quality and Added Value is a primary goal PMI continuously strives for.

We are looking for an experienced Quality Assurance Engineer to be a part of the team by providing customer service and technical expertise to meet our customer's requirements.

View our company website at http://www.pmi-cal.com

Duties and Responsibilities:

• Direct Quality Assurance Program; Responsible for ensuring quality system compliance to Precision Measurements Inc.’s Quality Policy, system regulations and standards. Develops and maintains an annual internal audit schedule in accordance with Quality Policy. Manages resources and conducts audits per the approved schedule and per procedural requirements, selecting auditors on the basis of experience and training. Performs additional focused audits as required by management. Report to the CEO on the progress of audits and validation plan activities.
• 17025 and Z540.3 uncertainty budget's
• Prepares and issues detailed audit reports in a timely fashion. Maintains audit observations tracking system. Ensures appropriate corrective actions are implemented and conducts effectiveness verifications. Monitors and reports status of open audits to ensure timely closure.
• Trains internal auditors as necessary, in audit principles and techniques. Responsible for annual quality system training for all personnel.
• Maintains audit skills, certification, and awareness of current and developing audit requirements. Maintains knowledge of current and developing industry quality standards and regulations.
• MaintainISO 9001:2015 Quality certified and ISO/IEC 17025:2017 ANSI/NCSL Z540-1-1994 (R2002 programs and prepare for audits
• Perform and direct customer audits
• Personnel training
• Interact with customers regarding quality issues
• Ensure that processes needed for the quality systems are established, implemented and maintained.
• Reporting to management on the performance of the quality management system and the need of improvement.
• Analyze information from sources such as processes and work operations affecting quality, audit results and quality records to identify trends or areas requiring improvement.
• Manage laboratory calibration standards scheduling and ensure calibration standards availability
• Utilize and support a Quality Management System in according with industry standards
• Interface with company staff to meet contract requirements, customer relations and report issues when necessary
• Implement and sustain a Continuous Improvement Process for laboratory equipment and calibration procedures while meeting or exceeding industry standards
• Evaluate results of calibrations for certificate acceptance to deliver to customers
• Assess compliance or operational risks and develop quality risk management strategies.
• Disseminate written policies and procedures related to compliance activities.
• Develop, apply and maintain systematic tests for validation tools and infrastructure needed for quality system validation and revalidation.
• Analyze and write test standards and procedures.
• Analyze test results to ensure correct functionality, determine root causes of failures and recommend corrective action.
• Consult with management in resolution of problems and provide feedback in preparation of technical appraisals.
• Other duties as assigned.

Required Skills:

A requirement for this position is demonstrated certified lead auditor training and experience pursuant to ISO 9001:2015 Quality certified and ISO/IEC 17025:2017 ANSI/NCSL Z540-1-1994 (R2002) 21CFR820 regulations, and ISO13485 a must. Must also have a deep knowledge of medical device relevant regulatory requirements, and demonstrate a willingness to keep abreast of regulatory changes. Must have sound reasoning skills and be able to problem solve. Be able to lead and to work effectively in teams. Excellent problem solving skills, using industry accepted concepts and tools to solve complex problems in creative and effective ways as they apply to compliance issues. Excellent written and communication skills are a requirement for this position. Strong testing skills both in black box and white box. Can do systematic analysis and debug in depth and identify the root-cause.

Qualified candidates will also meet the following requirements:

• U.S. Citizen or permanent residence status

• A College Degree or equivalent work experience in Quality

• Computer literate – Proficient with Microsoft Office programs

• Excellent verbal and written communication skills are a must.

• Results Oriented Professional – Self-motivated and Persistent – Driven to meet or exceed goals

• Capable of understanding industry and customer requirement

Compensation:

PMI provides employees with a complete salary/benefit package including Medical, Dental, Vision, Life, Vacation, and 401(k) w/matching.

Come join our team!

Job Type: Full-time

Pay: $85,000.00 - $155,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Relocation assistance
• Vision insurance

Schedule:

• Monday to Friday

Experience:

• Quality assurance: 4 years (Preferred)

Work Location: In person