Quality Assurance Specialist

The Quality Assurance (QA) Specialist is responsible for ensuring that products, processes, and systems meet established quality standards and regulatory requirements. This role involves developing, implementing, and maintaining quality systems, conducting inspections and audits, analyzing data, and driving continuous improvement across operations.

Key Responsibilities

· Champion and uphold the company’s values, vision, mission, and quality policy in all activities.

· Develop, implement, and maintain quality assurance systems, processes, and documentation to ensure compliance with company policies, procedures, and internal controls.

· Conduct inspections, audits, and reviews in accordance with industry standards (e.g., ISO, ITAR) and regulatory requirements.

· Investigate customer complaints and product nonconformances; manage RMAs, NCRs, product holds, and defective material disposition while leading root cause analysis and implementing corrective and preventive actions.

· Collect, analyze, and report quality metrics while maintaining accurate records, certifications, and documentation.

· Own and maintain Quality Management Systems, including ISO compliance, customer audits, and regulatory audits.

· Serve as the primary point of contact with customers, suppliers, and regulatory agencies on quality-related matters.

· Partner with production, engineering, and supply chain teams to uphold quality standards.

· Develop and deliver training for new and current employees on quality standards and inspection practices, including methodologies, blueprints, techniques, and defect identification.

· Lead process improvement initiatives using Six Sigma, Lean, or Kaizen methodologies.

· Provide inspection support during peak workloads or staff absences to ensure uninterrupted operations and compliance.

· Oversee incoming material inspections, including monthly and annual audits.

· Perform on-site calibrations of tools and instruments according to documented procedures and industry standards; coordinate and track external calibrations to ensure all equipment remains within its calibration cycle, maintaining accurate and complete records of procedures, results, and maintenance history.

Qualifications/Education/Skills Required:

· Bachelor's degree in Quality, Engineering, Manufacturing, or related field preferred.

· Strong working knowledge of quality systems and standards (ISO 9001).

· Minimum 3-5 years of experience in quality assurance, with at least 2 years in a management or leadership role.

· Proven expertise in diverse manufacturing areas, including punch and die tooling, medical device production, and precision engineering.

· Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

· Experience with audits, root cause analysis, and quality tools (FMEA, SPC, MSA, PPAP, 8D, etc.).

· Proficiency with quality management software, ERP systems, and Microsoft Office.

· Excellent communication, leadership, and interpersonal skills.

· Ability to work in an office and manufacturing environment

· May require occasional travel to suppliers or customers.

· Able to stand, walk, and perform inspections on the production floor.

Work Environment:

Manufacturing floor environments

Controlled temperature environments

Travel to client sites, conventions and trade shows

Expected Hours of Work: This is a Full-Time salary position required to work Monday through Friday, with occasional overtime as needed.

Travel:

Up to 10%