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Urgent! RA/QA Manager Job Opening In Everett – Now Hiring FlUKe Health Solutions



Job description

Responsibilities

  • Leads and participates in formal problem-solving processes, conducts root cause and corrective action investigations for quality failures, including those occurring in supplier, in-house processes and Client-side findings.
  • Supports the Director, RAQA for all Quality and Regulatory strategy plans, actions, implementation and upskilling as the Business grows.
  • Leads overall site compliance efforts, including, but not limited to:
  • Support for regulatory meetings with FDA.
  • External health authority inspections and audit readiness and logistics.
  • Front room audit host, RA/QA Subject Matter Authority, and/or backroom support.
  • Key liaison for agency communications as the need arises.
  • Lead followup activities for post-inspection root cause and correction action plan for identified corrections.
  • Completion of essential functions includes the effective application of: Gage R&R Studies, Design of Experiments, Failure Mode and Effects Analysis, Statistical Process Control, the determination of Operating Characteristics for Sampling Plans, and statistical analysis to effect quantifiable product and process improvements.
  • Fulfills QA/RA subject matter authority role for all functional areas.
  • Maintains Risk Management conformance to 14971 requirements, including governance of risk tools such as FMEA, Hazard Analysis, Risk-Benefit, etc.
  • Drives effective and efficient improvement of inspection and test methods, sampling plans, and process control plans.
  • Prepares and conducts training sessions and presentations in support of quality objectives.
  • Actively participates in new product development teams and sustaining design change activities and fulfills RA/QA required actions.
  • Lead the site CAPA system and ensure effective CAPA Review Board.
  • Lead all aspects of the Complaint system for timely complaint handling and MDR reporting ability.
  • Maintains applicable licenses and registrations to support global market.
  • RA/QA review for customer-facing marketing materials per FHS processes.
  • Supports all facets of the internal audit system including scheduling, auditing, reporting, and corrective actions.
  • Supports all facets of the supplier qualification and audit system including scheduling, auditing, reporting, and corrective actions with follow-ups.
  • Maintains a professional working relationship with internal and external customers and support staff.
  • Provide metrics to Leadership for overall compliance initiatives and report on health of the QMS.
  • Actively lead, support, mentor and develop RA/QA team members and others as needed.
  • Provide resource assignments across team members to support all cross functional business activities.
  • Qualifications

  • Bachelor’s degree (B.S. or equivalent experience) in engineering or science field from a four-year college or university.
  • Consistent track record to lead, grow in a Leadership position, and enable Team members to grow as well.
  • Minimum of seven years’ experience in Quality Assurance and three years’ experience in Regulatory Affairs in an FDA regulated industry.
  • Four year’s people management experience.

    Track record of building and leading high-performance teams.
  • Working knowledge of Quality Management Systems –.

    21 CFR Part 820, ISO 9001/13485, ISO 14971, ISO 17025 in development and manufacturing environments.
  • Marked ability to learn new applicable standards, resolve how they apply to the Business and provide related guidance cross-functionally.
  • Strong interpersonal skills with the ability to be a standout colleague and Leader; setting a professional tone and establishing a collaborative partnership within the department and other areas of the Company to optimally resolve problems.
  • Ability to interpret trends and data, translating the information into actions, outcomes, and improvements.
  • Excellent documentation skills, with a proven process orientation and effective attention to detail.

  • Required Skill Profession

    Operations Specialties Managers



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      Unlock Your RA QA Potential: Insight & Career Growth Guide


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      Fluke Health Solutions interview tips for RA/QA Manager

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