Quality Assurance Specialist

3 weeks ago

Redmond, Washington, United States iMPact Business Group Full time

Job Title: Quality Assurance Specialist

Job Summary:

We are seeking a Quality Assurance Specialist to join our team at iMPact Business Group. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes.

Key Responsibilities:

  • Work closely with Operations and business functions to ensure quality performance of products and processes.
  • Collaborate with internal cross-functional and supplier teams to address top quality issues.
  • Own identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action records (CAPA), managing the timely processing and closure of NC and CAPA records within the electronic management system, Trackwise.
  • Support execution and analysis of manufacturing-related complaint investigations and product field actions.
  • Investigate and disposition internal non-conforming product within MRB, issuing NCs as appropriate.
  • Communicate and collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as required.
  • Execute and manage Supplier Initiated Change Requests (SICRs) received from suppliers, engaging with cross-function teams for assessment and approval.
  • Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
  • Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.
  • Engage in the development and improvement of internal manufacturing and distribution processes for existing products.
  • Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP) activities for supplier changes.
  • Participate in and potentially lead the creation and/or review of new or modified procedures.
  • Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.

Requirements:

  • Bachelor's Degree in science/technical field.
  • Minimum of 3 years of experience.
  • Operations/Manufacturing Experience.
  • CAPA/NCs Experience.
  • SAP/ERP Systems experience. TrackWise a plus.
  • Strong quality background with CQE and/or LSSGB or LSSBB certification.
  • Previous medical device industry experience desired with understanding of US and International Medical Device Regulations, familiarity with ISO 13485, GDP, GMP as well as experience interacting with regulatory agencies (FDA, MoH, TUV, etc.) and in working in compliance risk situations.
  • Strong knowledge of and experience with key Quality concepts (e.g. Risk Management, CAPA, Audits, Statistics, DMAIC, DFSS).

About Us:

iMPact Business Group is a results-oriented service organization committed to providing our candidates and clients with unparalleled service and results. We leverage 200+ years of combined experience to develop Strategic Staffing Solutions that deliver best-in-class results while reducing overall costs associated with staffing initiatives.

Benefits:

  • 401(k) matching.
  • Comprehensive dental, vision, and health insurance.
  • Flexible schedule options.
  • Health savings account.
  • Life insurance.
  • Paid time off.
  • Professional development assistance.
  • Employee assistance and discount programs.
  • Referral program.
  • Retirement plan.
  • Tuition reimbursement.

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