Project Engineer - Device Quality in Wilson, NC at Apex Life Sciences

Date Posted: 5/16/2018

Job Snapshot

Job Description


ESSENTIAL DUTIES

  • Actively represent Device Quality function on commercial value streams and/or product/core development teams to ensure compliance with regulatory and Merck requirements
  • Participates on internal teams supporting development and commercialization of combination products and oversight of quality issues, reviewing technical data to identify and solve quality issues.
  • Audits and approves Design Control and Device Risk Management documentation for applicable regulatory filings, clinical supply, development, and design transfers..  Evaluate deficiencies and assess impact on compliance status. 
  • Provide guidance to Packaging Commercialization or Device Development personnel to ensure design control tools, and internal SOPs are implemented in an effective manner, including best practices for systems engineering or reliability. 
  • Lead or participate in design reviews to ensure adequate design control readiness and compliance.
  • Drafts quality plan, and validation master plans, protocols, and engineering studies that encompass the life-cycle and risk-based approach of development and sustaining activities.
  • Provide input to design house experts to review material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured at the site.
  • Support site personnel on lifecycle Management events: Change Controls, Deviations, etc. for site commercial combination products and/or connect them to appropriate MDCP Q product lead/QS sub-system owners as appropriate 
  • Collaborate with MDCP Q colleagues during site visits as liason for design transfer activities.
  • Deliver and reinforce training for Site personnel per MDCP Q strategy and content, as needed.
  • Support regulatory inspections, and third party audits on MDCP, and support product lead as requested for PAI inspections.
  • Participate on MDCP platform site Quality Councils, attend tier level meetings, Deviation huddles, etc. to gain insight and identify opportunities for continuous improvement, as needed 
  • Provide regular updates to MDCP Q on site: engagement, capability needs, issues, etc.  and escalate issues to MDCPQ Director
  • Maintain a daily site presence with the exception of planned OOO 

REQUIREMENTS

  • Bachelor’s degree in Science or Engineering or associated field required
  • 5+ years with BS,3+ years experience with MS, or 1+ years experience with Ph.D., with emphasis in Quality Engineering, Quality Assurance or Design Assurance in the Pharmaceutical, Biotech, medical device industry, or experience in related engineering/Scientific areas, e.g. R&D or Manufacturing.
  • Design controls, purchasing controls, process controls.
  • Risk analysis (ICH Q9 and/or ISO 14971)
  • Medical Devices (ISO 13485, 9001, IEC 62304, 92/43EEC))
  • Root cause analysis and/or Problem solving techniques , CAPA, and Auditing
  • Strong understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (QDP); project management principles; and ICH Q8, Q9, and Q10 procedures is desirable.
  • Knowledge of medical device regulations QSR (21CFR part 820s), and compliance in a specialized area with experience in their application, including current GMPs for combination products (21CFR part 4). 
  • Demonstrated ability to work collaboratively in cross functional teams, virtual teams, and networks. Working knowledge of technical aspects of device development and commercialization. Development, product approval, and/or inspection experience with the medical device constituent of a combination product is an asset. 
  • Certified Lean Six Sigma Green Belt or Black Belt and/or  ASQ Certified Quality Engineer (CQE) or Certified Biomedical Auditor (CBA) is strongly desired.
  • High proficiency with Microsoft Word, Microsoft Excel, Power Point and statistical tools (e.g., Minitab or Sigma XL) is required. Strong documentation skills are required. 
  • Ability to work independently, or within a team structure, and on multiple projects, with flexibility to adapt to changing priorities is required. This candidate must have excellent communication and interpersonal relationship skills.
  • Minimal travel domestically and internationally (<15%) may be required.