Quality Assurance Specialist

2 weeks ago

Westlake, Ohio, United States WesternScott Fetzer Full time

Position Overview:

The Quality Assurance Specialist plays a crucial role in ensuring product integrity and process excellence through the formulation and implementation of quality strategies and ongoing enhancements. This role requires the ability to pinpoint, execute, and oversee improvements that minimize defects, rework, and waste. Responsibilities include the development and maintenance of validation plans and protocols, as well as addressing and investigating quality concerns that affect customer satisfaction and product safety. The specialist will drive process enhancements based on quality metrics, cycle times, and identified root causes, while also participating in the preparation and support of third-party and regulatory inspections.

Key Responsibilities:

  • Lead initiatives for Corrective Action / Preventive Action (CAPA) and Quality Issue Investigations (QII).
  • Respond to and mitigate risks associated with nonconformance discoveries.
  • Collaborate with manufacturing engineering to troubleshoot production methods and challenges.
  • Conduct root cause analyses and formulate corresponding corrective action plans.
  • Determine appropriate material disposition for nonconformance situations.
  • Plan, execute, and supervise product inspections to ensure compliance with specifications and deliverables.
  • Identify systemic corrective actions and root causes for both products and processes.
  • Provide leadership and quality oversight for inspection and assembly, execution of procedures, and overall safety.
  • Design and deliver training programs aimed at continuous improvement and quality function execution.
  • Lead validation efforts for processes, equipment, and software.
  • Support audits for regulatory inspections, customer evaluations, and third-party assessments.
  • Conduct internal audits to maintain and enhance the quality management system.
  • Assist in complaint investigations and implement both immediate and long-term corrective actions.
  • Develop and implement changes to foster continuous improvement.
  • Create and execute Quality Plans for new product and process initiatives, acting as the quality representative during development.
  • Stay updated on industry standards, regulations, and quality management system expertise.
  • Support the creation of inspection methods, tools, and equipment.
  • Engage in design and process risk management activities.
  • Identify, procure, and/or design gauging and equipment necessary for the inspection of machined components and final product assembly.
  • Conduct process failure mode and effects analysis (pFMEA).

Qualifications:

To excel in this role, candidates must demonstrate proficiency in the essential duties outlined. The following qualifications are representative of the knowledge, skills, and abilities required:

Knowledge:

Understanding of validation concepts (process/equipment/software), root cause analysis, medical device regulations, ISO9001, ISO13485, 21 CFR 820, metrology, Statistical Process Control (SPC), gauge Repeatability and Reproducibility (R&R), engineering prints/drawings, and statistical sampling.

Familiarity with machining processes such as turning, drilling, milling, deburring, cleaning, and plating.

Skills/Abilities:

Capability to develop and lead validation efforts for processes, equipment, and software. Ability to identify, respond to, and mitigate risks associated with nonconformance events. Proficiency in developing and implementing changes to support continuous improvement.

Experience:

  • Bachelor's degree in a relevant field such as science, engineering, or manufacturing technologies, or an equivalent combination of education and hands-on experience.
  • 3-5 years of experience in quality and manufacturing preferred.
  • Relevant certifications in quality or manufacturing processes (Lean, Six Sigma, CQE, etc.) are preferred.
  • Experience in a regulated environment is advantageous (ISO9001, ISO13485, 21 CFR 820, etc.).
  • Specific technical training as required.
  • ISO9001 or ISO13485 lead auditor certification is preferred.

Certificates, Licenses, Registrations:

A valid driver's license is required for occasional travel between facilities.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this role. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

The typical workday involves periods of sitting, standing, desk work, hands-on product inspection, and activities typical of a quality assurance specialist. The work schedule is generally Monday to Friday, with occasional overtime as needed based on workload and organizational commitments.

Work Environment:

The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this role. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

The work environment includes both a standard administrative office area and a manufacturing shop floor, with specific areas requiring eye and hearing protection.

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