Quality Engineering Senior

Client
Medical Device Company

Employment Type
Contract on W2 (Need US Citizens Or GC Holders Only)
No H1B’s

Location
San Diego, CA (can work at either BD location - Brea as on the REQ or San Diego (SD location is Building D, 1000 Pacific Mesa Blvd, San Diego, CA 92128))

Duration / Hours
9+ Months Contract, 40 hours per week

Position
Sr. Quality Engineer

Description
Can work at either BD location, Brea as on the REQ or San Diego (SD location is Building D, 1000 Pacific Mesa Blvd, San Diego, CA 92128).

Must Haves On The Resume

Risk Management Knowledge

Design controls exposure

Knowledge with Engineering change control processes

Targeted knowledge with MDR

Responsibilities

Support modification and maintenance of quality system procedures for the design center that comply with ISO 13485:2016 and 21 CFR 820 requirements

Implement Corporate and Business level Quality System procedures for the design center locations under supervision

Facilitate internal quality system audits per the procedural requirements

Support the management of external audits

Lead or support the development of content for the management review process

Update and report on monthly quality metrics

Provide inputs on revisions to Corporate and Business level procedures as necessary

Support supplier management efforts for the design center

Maintain outsourcing relationships with internal customers and suppliers by management of quality agreements

Scope Of Responsibilities

Work is performed without appreciable direction

Determine and pursue course of action necessary to obtain desired results

Educational Requirements

A minimum of Bachelor’s degree in Science or related discipline

Certified ISO 9001/13485 Lead auditor is desirable

Knowledge of Design Control, Risk Management and QMS processes

Minimum 1-2 years of experience developing and sustaining quality systems of medical devices

Knowledge And Skills

Exposed to internal and external audits as an auditor and/or auditee

Some knowledge of applicable regulatory and industry standards (21 CFR 820, ISO 13485, MDD, MDR, ISO 14971, etc.)

Good technical writing, communication skills, and managing small quality system projects

Desirable knowledge with Design Control/ Change control process, CAPA, Deviations and Non-conformances

Design Control

EU MOD/MOR

Change control

Risk Management

Process Validation

Identification of CTQ's

Handling of deviations and non-conformances

Test method validations

Proper Use of Statistics (Sampling Plans)

Advise on Regulations and standards

Liaise with Manufacturing Plants

CAPA

Root cause investigation and implementation of corrective / preventive actions

Requirements

Bachelor's Degree

A minimum of 9 years of relevant experience or a combination of equivalent education and relevant experience

Minimum 2-3 years of experience supporting design assurance for medical devices

Extensive knowledge of applicable regulatory, Corporate and/or Unit requirements

Quality Engineering tools, Statistics, Problem Solving, strong Interpersonal Skills

Leadership and all forms of communication

ASQ Certificate(s) desirable (but not required)

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