This job has expired

Medical Device Engineer

Employer
Parker Laboratories Inc.
Location
Fairfield, NJ
Closing date
May 18, 2022

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Sector
Science, Physical Sciences and Engineering, Biomedical Engineering
Organization Type
Corporate
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DEPARTMENT - Quality

JOB TITLE: Medical Device Engineer

The Medical Device Engineer will lead and support Quality Assurance activities that ensure compliance with U.S. and international regulations, standards, and guidance related to Class II medical devices. The Medical Device Engineer will form part of a multi-disciplines, cross functional team that focuses in improving and assuring the quality of our Company's products.

Responsibilities:

The role is key to the success of the Quality organization. The person in this position must be comfortable leading and taking responsibility for the following areas of Quality: Final Product Release, Process Deviation Requests, Non-Conformance Reports, Engineering Change Orders, Support Lead or Support audits (internal audits, customer audits, and supplier audits)

Additional Responsibilities:
  • Organize Task-focused teams in solving quality opportunities for short term and long term results
  • (Took off support) Qualification and validation activities (equipment, test method, process) using sound statistical rationale.
  • Utilize widely available statistical tools to improve the quality of company products (Control charts, Analysis Diagrams and tools)
  • Make use of basic financial metrics to drive quality opportunities (ROI)
  • Determine and analyze trend results to input into post market product failure data
  • (Re-arranged up) Communicate with internal and external resources globally as necessary to obtain details related to customer complaints
  • Provide training and mentoring in concepts related to Quality Assurance and the Quality Management Systems (e.g. CAPA, qualification/validation, risk management, problem-solving, root cause analysis, Corrective Action/Preventive Action (CAPA) and Complaint Handling / Post Market Surveillance)
  • Perform adverse event filings, including medical device reporting (MDR) and medical device vigilance (MDV) reports
  • Perform document reviews and revisions
  • Supports review and investigate customer complaints


Requirements:
  • Ability to adjust to changing priorities in order to maintain alignment with business and operational needs
  • Mustpossess strong analytical and problem solving skills, and the ability to make important decisions independently.
  • Experience in FDA regulated industry (Class I or Class II medical devices desired)
  • Experience with electronically based Quality Management Systems preferred
  • Experience working in chemical operations/manufacturing (cosmetics, pharma, or drug, preferred) or medical device industry
  • Basic knowledge in 21 CFR Part 820, 21 CFR Part 11, ISO 13485, ISO 14971
  • Ability to translate guidance documents from regulatory bodies into practical SOPs and forms
  • ASQ training or certification (CQE) is desirable, but not required
  • Manage company's CAPA program
  • Perform document reviews and revisions
  • Previous Team Lead experience preferred


Education:

· Minimum of a Bachelor's degree. B.S in Science or Engineering discipline: Mechanical, Bio-Medical, Chemical Engineering. Masters degree in Science or Engineering field a plus.
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