Quality Specialist
Quality Specialist
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1 Vacancy
Job Description
As a Quality Specialist on our Fluke Health Solutions Quality Assurance team you will be responsible for ensuring compliance with established NQA1 10CFR 50 Appendix B ISO 9001 and other applicable regulatory standards and requirements. We are seeking a dedicated and detail-oriented Quality Specialist to join our team. The Quality Specialist will be responsible for overseeing incoming in-process and final inspection activities managing supplier quality assisting with problem-solving using various tools manage training documentation and ensuring compliance with NQA-1 standards.
Your primary contacts will be:
Internal:Quality Assurance and Regulatory Affairs team Operations team Engineering team Business Units as well as all other functional team members.
External:Industry peers Regulatory agencies Customers Notified Body Suppliers.
Responsibilities:
- Perform and oversee incoming inspections of raw materials components and finished products.
- Conduct in-process inspections to ensure compliance with quality standards.
- Perform final inspections to verify that finished products meet specified requirements.
- Document inspection results and maintain records.
- Evaluate and monitor supplier performance to ensure consistent delivery of quality materials.
- Coordinate the Supplier Corrective Action Request (SCAR) program including monitoring response timeliness and effectiveness of corrective actions. Collaborate with suppliers to resolve quality issues and implement corrective actions.
- Conduct supplier audits surveys and assessments as required as per 10CFR50 Appendix B.
- Assist in identifying and resolving quality-related issues using problem-solving tools (e.g. 5 Whys Fishbone Diagrams Root Cause Analysis).
- Initiate NCRs and SCARs and work with cross-functional teams to address quality concerns and implement improvements. Track and report on the effectiveness of corrective and preventive actions.
- Ensure all quality personnel are adequately trained and maintain training records.
- Maintain compliance with NQA-1 standards and ensure all processes and procedures align with regulatory requirements.
- Participate in internal and external audits to ensure ongoing compliance with NQA-1 standards.
- Assist site quality manager to schedule and prepare management review meetings.
- Conduct and detail internal audits and gap analyses against specified requirements.
- Collect analyze and assemble pertinent quality data for periodic reviews.
- Participate in and support external audits as the need arises.
- Collect analyze and assemble pertinent quality data for periodic reviews.
- Perform other job-related duties as assigned.
Qualifications:
- BA/BS in Engineering or physical sciences preferred. Equivalent experience and/or ASQ certifications accepted.
- 5 years of experience in a Quality Specialist role within a manufacturing environment.
- Knowledge of quality inspection methods tools and equipment.
- Strong problem-solving skills and experience with problem-solving tools.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Strong attention to detail and organizational skills.
- Proficiency in Microsoft Office Suite and Quality Management Software.
- Must have knowledge of the ISO 9001:2015 and/or NQA1 standards
- Prior experience with 10CFR50 Appendix B is highly preferred.
- NQA1 Lead Quality Auditor is highly preferred.
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Required Experience:
Unclear Seniority
Employment Type
Full-Time
