Quality Assurance Specialist

2 weeks ago


Frederick, Colorado, United States Food Management Search Full time

Quality Assurance Specialist

Job Overview

The Position:

As a Quality Assurance Specialist, you will collaborate with the team to oversee and enhance the integrity of our operational processes and deliverables. Your role will involve establishing quality benchmarks, creating quality assurance frameworks, and guiding interdisciplinary teams in resolving issues, leading to effective and innovative corrective measures.

An ideal candidate for this position should excel in problem-solving and be committed to ensuring that our processes and products consistently align with customer expectations and adhere to all applicable regulatory standards.

Key Responsibilities:

· Formulating and executing quality benchmarks and frameworks.

· Monitoring and evaluating quality metrics while possessing a solid understanding of statistical process controls.

· Familiarity with Regulatory Standards: ISO13485, AS9100, ITAR, 21 CFR Part 11, REACH/RoHS, CMRT.

· Proficient in Quality Methodologies: 5 Whys, Fishbone Diagram, APQP, PPAP, PFMEA, SPC, MSA.

· Partnering with operational teams to devise and implement quality controls and enhancements.

· Ensuring that workflows, processes, and products meet customer and regulatory standards.

· Leading the analysis and resolution of product or production challenges.

· Driving initiatives for corrective actions, solutions, and ongoing improvements.

· Serving as the primary contact for quality-related inquiries and managing feedback on quality performance.

· Conducting both customer and internal audits, as well as assisting with external audits.

· Addressing supplier-related issues, including issuing Supplier Corrective Actions and ensuring follow-up.

· Acting as the Quality Representative during Material Review Board (MRB) meetings and New Product Introductions (NPI).

· Overseeing document management and control.

· Managing supplier relationships, including maintaining the Approved Vendor List and overseeing regulatory and certification updates.

Qualifications:

· A minimum of 5 years of experience in Quality Assurance within the food manufacturing sector.

· A bachelor’s degree in engineering or a related technical field.

· Active ISO13485 Lead Auditor certification.

· Strong knowledge of Geometric Dimensioning and Tolerancing (GD&T).

· Proficient in Microsoft Office Suite, including Word, Excel, and PowerPoint.

· Excellent communication and interpersonal abilities.

· Strong analytical and problem-solving capabilities.

· Self-motivated, inquisitive, and results-oriented.



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