Position: Sr. Quality Engineer

Location: San Diego, CA

Duration: 9+ Months Contract

Total Hours/week: 40.00

Client: Medical Device Company

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B’s

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)
NOTE location interested in on submittal

3 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 project
• 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
CAPA- Root cause investigation and implementation of corrective / preventive actions
• Proper Use of Statistics (Sampling Plans)
• Advise on Regulations and standards
• Liaise with Manufacturing Plants
• Provide functional support to cross-functional teams G Support Internal and external audits

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.
Applicable Regulatory and Industry standards (21-CFR-820, ISO '13485, MOD, MOR, ISO
14971,ISO 10993, etc.) Knowledge and Skills:
? Quality Engineering tools, Statistics, Problem Solving, strong Interpersonal Skills,
Leadership, all forms of Communication
• ASQ Certificate(s) desirable (but not required)