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Senior Quality Engineer

Company: TC Industries Of Canada Company
Location: Milpitas
Posted on: September 12, 2020

Job Description:

Modulus is a contract manufacturer established in 1972 and has remained in the heart of Silicon Valley. Modulus specializes in the development and manufacturing of high reliability Industrial and Consumer products and Class II and Class III medical devices. We help customers bring to market highly innovative products, some of which are recognized as firsts in the manufacturing industry.

Purpose of the job

The Sr. Quality Engineer will be responsible for assessing, improving and maintaining Modulus’ Quality System, policies and procedures to ensure all processes, components, subassemblies and finished products are manufactured in compliance with applicable FDA and ISO requirements.

Requirements

Manage and maintenance of Modulus Quality System in full compliance with ISO 13485 and FDA QSR

Support Quality Assurance activities, including but not limited to internal and external audits, complaint handling, supplier management evaluation, NCMRs, CAPAs, management reviews, product release and document control activities

Perform trending analysis (Quality Metrics) on a routine basis

Manage the complaint handling process in collaboration with other affected departments to ensure that complaints are documented, investigated and closed in a timely manner

Ensure systemic product quality issues are identified and pursued through the CAPA program

Manage the Non-conforming Materials Review (NCMR)/ Deviations program in collaboration with Operations to ensure timely reporting, analysis, and resolution of non-conforming material/ product incidences. Address systemic quality issues with suppliers or internal groups

Manage Incoming Quality Control activities to ensure timely inspection, including First Article Inspections, review and release of materials. Identify and report nonconforming materials

Perform/manage review of lot history records and disposition of product (subassembly and finished goods)

Create, review and approve Quality System Documents

Oversees Quality Inspectors within Modulus

Provide management support to insure proper IQC, in-process and finished product test procedures are in-place, and materials and material and products are evaluated and released in an efficient and through manner

Establish and direct completion of regularly scheduled internal audits

Interface and support audits by external regulatory bodies and any necessary follow up activities to support continued QMS compliance

Other duties/ activities may be necessary to support departmental or company goals

Education and/or job experience

7-10 years quality assurance/engineering experience in the Medical Device industry. Minimum of five years managerial experience required

BS in life sciences, Engineering or equivalent

Knowledge of FDA and ISO regulatory requirements and guidelines related to medical devices

Experience performing lot disposition activities, managing quality processes and issues, and performing systems related audits is essential

Skills and Specifications

Ability to motivate and influence people

Organizing, planning, and problem-solving skills

Good interpersonal and communication skills

Keywords: TC Industries Of Canada Company, Milpitas , Senior Quality Engineer, Other , Milpitas, California

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