Quality Engineer

Hopkinton, Massachusetts | Freelance | Job ID #58181 |
Posted Last Month
 

Provide quality support for product Lifecyle management. Responsible for development activities of medical device products following design transfer requirements and internal procedures. Provides general engineering services and support for product manufacturing and quality control. The PQE is provided limited direction from the Manager to maintain the complaint and investigation processes and is capable of performing all activities and takes a leadership role with projects and product support.

Essential Duties and Responsibilities:

  • Compiles and analyzes quality system metrics (e.g. management review, compliance metrics, post market quality assurance, etc.) in order to ensure key process indicators are identified, measured and action driven. Identifies unacceptable trends and drives suitable corrective action
  • Facilitate and actively contribute to the risk management activities per ISO 14971:2019: Risk Management Plans, pFMEA’s, Risk Control, etc. for new and released products
  • Supports nonconformance investigation, disposition and release activity as applicable
  • Creating appropriate harm/hazard analysis/health hazard assessment for issues potentially impacting patient outcomes
  • Assists with the review of complaints to determine potential adverse events
  • Assists with the department metrics and works with others to ensure department goals are achieved
  • Remediation of product documentation for changes in product compliance for new or updated regulations (i.e., MDR, IVDR)
  • Identify, investigate and implement corrective and preventive actions (CAPAs)
  • Participate/Lead projects related to Design Transfers
  • Review technical product documentation including device master records (DMRs), drawings, bills of materials, test protocols and reports, manufacturing work instructions, engineering change orders (ECO), etc.
  • Work with manufacturing engineer/process engineer to ensure process controls are in place
  • Review and/or approve reports for: test method validations, design transfer, pilot production, and process validations (IQ, OQ, PQ)
  • Write, review and / or approved quality plans to support product activities both internal and external
  • Assist in external & internal audits
  • Participate in project teams and company initiatives to assure compliance with Quality System requirements while achieving company objectives
  • Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE)

Qualifications:

  • Bachelor’s degree or higher in related discipline. Relevant work experience may offset the educational requirement
  • Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) certificates from American Society for Quality (ASQ) are a plus
  • 7+ years of experience as a Quality Professional in the Medical Device industry desired

Skills:

  • Knowledge of ISO 13485 and ISO 9001 is essential as well as FDA and cGMP regulations and documentation practices
  • Knowledge of Risk Management and applicable standards

Employer Details:

  • Onward Search is an equal opportunity employer, dedicated to a policy of non-discrimination in an employment with regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, veteran status or any other classification protected by federal, state and local laws and ordinances. Candidates must be at least 18 years old to be considered for employment. EOE/M/F/D/V/SO.
  • In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
  • The client is unable to support 1099 / Corp-to-Corp or Independent Contractor arrangements at this time. All freelancers will be paid as W2 employees.
  • Onward Search is a drug-free workplace.
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About Onward Search

Onward Search helps connect creative, marketing, and technology talent with top jobs at the nation's most recognized companies and digital agencies. We offer a full range of recruitment and staffing solutions to include freelance / contract, temp-to-perm, and permanent placement.