10 days old

Sr. Quality Engineer

Merz North America, Inc
Mesa, AZ 85201
  • Job Code
    SRQUA002477

The position is responsible for providing strategic leadership and support for the R&D Quality activities related to the Merz Aesthetics R&D Medical Device functions. Activities include, but not limited to general Product Development / Design Control requirements, Software Quality, Risk Management, Manufacturing Transfer, and Clinical readiness. Position will operate as a liaison among the various R&D functions and the Quality Operations department to assure strategic alignment and compliance.


REQUIREMENTS


  • Quality Engineer on Device development project teams
    • Execute and guide teams through Design Control requirements

    • Support transfer to manufacturing

    • Support preclinical and clinical planning and readiness

    • Support regulatory submissions

    • Manage project timelines as defined by department, project team, and corporate objectives

  • Risk Management
    • Facilitate and provide input to risk management activities throughout all stages of the device development process

    • Manage the risk management plan, risk file and risk report for new products

  • Software Quality
    • Originate, review, and approve Software Quality Systems processes and operating controls in accordance with global industry standards, regulations, and requirements

    • Review, and approve the validation of computerized systems.

  • General R&D Support
    • Support R&D related audits, both internal and external

    • Support approval of R&D vendors/suppliers

    • Support R&D related SOP creation and maintenance

    • Support R&D related NCRs/CAPAs

    • Assist in ensuring applicability of current quality policies, procedures and objectives by keeping informed of the latest updates/modifications related to applicable regulations (ISO, Ministries of Health - FDA, EMA, Health Canada, TGA, ANVISA)

REQUIREMENTS


  • Bachelors Degree in Engineering.

  • Minimum of 6 years experience in Medical Device, Pharmaceutical and/or equivalent regulated industry.

  • Knowledge of regulatory requirements and standards for a medical device organization (i.e. 21CFR820, ISO 13485, ISO 14971, IEC 62304, ICH guidelines).

  • Certification(s) ASQ Certified Quality Manager; Certified Quality Engineer, or Certified Quality Auditor preferred.

  • Experience with FDA, European agency regulations, cGMP regulations, and Quality Management software is highly preferred.

  • Excellent written and oral communication skills with attention to detail.

  • Ability to supervise others.

  • Ability to work effectively in a global, matrix environment.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)

Research and Development





Posted: 2021-09-11 Expires: 2021-10-10
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Sr. Quality Engineer

Merz North America, Inc
Mesa, AZ 85201

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