May 15, 2019

QA Engineer

POSITION SUMMARY: 

Provide quality leadership to new product development projects, manufacturing process control and vendor qualification and/or management. Assist manufacturing group with the quality assessment of product issues for production and sustaining engineering support.

DUTIES AND RESPONSIBILITIES (essential functions of position): 

  • Oversee qualification activities and manufacturing support for medical devices, including IQs/OQs/PQs.
  • Develop and oversee execution of measurement equipment qualifications and test validations
  • Participate in project cross-functional teams for new product development to complete Design Control Deliverables, including design reviews, risk management, D/PFMEAs and verifications and validations.
  • Interface with Product and Manufacturing Engineering to identify and resolve product quality issues and lead reviews of such issues through the Internal Audit Program, CAPAs, NCRs and complaint reviews.
  • Develop and maintain company’s QMS through quality SOPs for compliance with standards and regulatory requirement.
  • Develop and maintain DHFs to establish Quality Plans, Measurement and Test Equipment Matrix ,CTQ parameters, sampling plans and acceptance criteria.
  • Complete and/or review DCRs in a timely and objective manner.
  • Monitor and report quality metrics in order to identify and implement CI initiatives.
  • Participate in internal, suppliers as well as regulatory body audits.
  • Interface with Engineering and Purchasing in all activities involving supplier identification, qualification and management.

ESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS: 

  • Bachelor’s degree in engineering or related discipline.
  • 5+ years in the medical device or related industry.
  • Must possess excellent verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.
  • Previous Quality engineering experience and demonstrated use of Quality tools/methodologies, test method development and validation, test execution, failure analysis and risk management.
  • Expertise in FDA 21 CFR 820 regulations, ISO 13485, ISO 14971.
  • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
  • Strong root cause analysis and statistical techniques skills.
  • Strong sense of urgency, initiative and teamwork.
  • Ability to travel approximately 20%, including internationally.
  • Professional with Microsoft Applications such as: Word, Excel, Outlook, Power Point and Visio.

NONESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS (not necessary but preferred):

  • Experience in the implantable medical device field with experience in Design Assurance, Quality Assurance, Design Controls and Risk Management.
  • An American Society of Quality Engineers (ASQ) certification is preferred (CQA, CQE, CSSGB)
  • Familiar with the following standards/regulations: Medical Device Regulation (MDR), Council Directive, Regulation (EU) 2017/745, Guidance on CE Marking.
  • Advanced knowledge of CAD software packages (AutoCAD, SolidWorks, etc.) and application of GD&T.
  • Experience with statistical software packages or add-ons such as Minitab, SigmaXL, etc.

**To apply for this opportunity, please send a resume and cover letter to svrabie@ctlmed.com referencing: QA Engineer

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