Quality Engineer (Medical)

company banner
Oxford Global Resources
"Quality Engineer", Capa, medical, compliant, audit, FDA, CFR, ISO, SEC, Protocol, Procedure, Quality management systems, processes, verification, document control, "contract manufacturer", 21 cfr 820, iso13485
Contract W2, 6 Months
Depends on Experience
Work from home available Travel not required

Job Description

Location: Menlo Park, CA – Hybrid Schedule 3 Days on-site

Length: 3-6 months-to-hire

Process: MS Teams Interview + on-site + possibly Director of quality sitting in Boston. 

Start Date: ASAP

 

JOB TITLE: Quality Engineer

REPORTS TO: Head of Quality

JOB PURPOSE: Support product quality and quality management system initiatives

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Supports the implementation and maintenance of the quality system in accordance with all applicable regulatory requirements and provides guidance and training to employees to execute company policies, procedures, and systems needed to fulfill worldwide quality system requirements as a medical device manufacturer
  • Carries out activities to support agreed business plans, budgets, products, and timescales
  • Serves as Quality Engineering representative on design teams for new products, added indications for use, and design improvement projects
  • Drives risk management activities (ensure compliant process)
  • Reviews and approves design/process verification and validation protocols/reports
  • Manages sterilization validation and on-going re-qualification (quarterly dose audits), Tracks and trends bioburden and sterility results
  • Supports 510k submissions and responses
  • Supports Operations with management of contract manufacturer, including review and approval of supplier change notifications and nonconformance reports
  • Works with contract manufacturer and Operations to resolve quality issues in production
  • Serves as CAPA Manager for corrective and preventive action programs
  • Serves as Complaint Manager - Receives, evaluates, investigates, and responds to customer complaints
  • Documents and submits adverse event reports
  • Performs verification of effectiveness of implemented actions for CAPA, audit responses, etc.
  • Supplier quality management
  • Reviews and approves change orders related to the product design
  • Supports Document Control personnel and processes
  • Coordinates internal audits as required; Generates response to internal audit findings and assists with response to FDA 483s
  • Conducts supplier audits as required
  • Provide Quality System training as required
  • Manages nonconforming material program
  • Monitors and reports Quality activities; Performs data analysis in support of management review meetings and periodic metrics

QUALIFICATIONS

  • Bachelor’s degree (BS) in an engineering field and ten or more years working in Quality for medical devices; or equivalent combination of education and experience
  • FDA GMP regulations (21 CFR 820) and/or ISO13485 Experience
  • 8-12 Years of Quality Engineering (Senior-level and/or prior QE Management experience is Preferred
  • Attention to detail
  • Critical thinking skills
  • Proficiency with Microsoft Excel, Word, PowerPoint


Company Information

Get Connected to Projects that Match Your Individual Talents

What sets Oxford apart? We take the time to get to know you and our clients so we can quickly make the right match. Our partnerships give us deep insight into the industries we serve so we can anticipate trends and uncover new opportunities. This allows us to consistently deliver for you and for our clients. That’s the Oxford difference.

A Little More About Us

Since 1984, Oxford has focused on building trust with each interaction. We're proud to create long-lasting relationships with the brightest minds in the industry while continuing to identify and drive initiatives to advance our clients' business. Anticipating industry trends and building a network of talent to provide technology and engineering expertise is the foundation of our business. We are committed to matching our consultants' experience to work that ensures they are most valued and fulfilled in their careers.

You'll also find the people that shape our own organization are some of the best in the industry, dedicated to making an impact and with you every step of the way.

Dice Id : cxoxpma
Position Id : 7643424
Originally Posted : 3 months ago
Advertisement