Quality Technician

Position summary

The Quality Technician III will lead the nonconforming event process and conduct production in-process documentation audits. This role will also complete appropriate quality records within the company and GMP guidelines, policies, and procedures.

Essential Job Functions

· Create/revise Quality Management System (QMS) procedures and documentation. Assist with the implementation of quality system improvements.

· Lead NCMR process and MRB meetings.

· Manage and report out NCMR Metrics

· Support operations with questions regarding quality standards and product quality.

· Maintain accurate records and report findings to relevant teams.

· Develop and implement plans to ensure the ongoing compliance of QMS.

· Develop and drive standard work for Quality Technicians

· Lead periodic cross-functional reviews of the line and paperwork audit program.

· Manage MRB Cage.

· Provide support for CAPA investigations, actions, and effectiveness assessments.

· Report to management on the status of NCMR and line/paperwork audits.

· Provide backup support for Quality personnel.

· Identify training gaps and support the development of QMS training materials to promote quality awareness and ensure compliance with company policies and procedures.

· Assist with issue resolution concerning the Quality System software.

· Assist with the issuance, investigation, and closure of Non-Conformance Reports, Complaints, and CAPAs within the Quality System software.

· Participate in second and third-party audits, including audit preparation, execution, reporting, and follow-up activities.

· Assist the internal audit program and the implementation of effective corrective actions.

· Perform internal audits to identify gaps and deficiencies and implement process improvement initiatives utilizing lean techniques.

· Document process audits and communicate results with Operations.

· Work with Operations and/or Quality to resolve manufacturing documentation issues.

· Effective organizational, oral, and written communication skills to facilitate an effective working relationship with customers, suppliers, and coworkers.

· Mentor and train Quality personnel.

· Read and comply with work instructions, and set up sheets, checklists, and standard work.

· Accurately record and report hours worked.

· Understand customer needs and the core business markets we serve

· Support and comply with the company Quality System, ISO, and medical device requirements

· Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance.

· Understand customer needs and the core business markets we serve.

· Participate in required company meetings.

· Maintain an organized work area (5S).

· Participate in the Operational Excellence Program.

· Complete all other work duties as assigned.

· Ability to work in a manufacturing environment.

Minimum Requirements, Education & Experience (incl. KSA’s and certifications)

· High school diploma or general education degree (GED) required

· At least 8 years of experience in a quality-related role

· Knowledge of inspection equipment use and maintenance

· Experience with leading or training others

· Problem solving and analysis

· Manage multiple requirements and deadlines

· Mechanical Aptitude

· Dexterity and hand-eye coordination

· Ability to use a microscope and hand tools

· Ability to cross-train in other areas of production when required

· Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)

· Clear and effective verbal and written communication skills

· Attention to detail

· Organizational skills

· Ability to work in a fast-paced team environment

· Ability to prioritize and multitask

Desirable Criteria & Qualifications

· Associate Degree or equivalent work experience

· 10+ years of experience in quality assurance

· Knowledge of ISO 9001/13485

· Quality Technician or Quality Assurance certifications

· ISO 13485 Internal Auditor Certification

· Customer-facing experience

· Quality systems experience in a manufacturing setting

· Continuing education, including participation in local chapters, associations, and/or organizations

This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range.