Demo

Quality Engineer

MBS Pro Staffing
Walton, KY Full Time
POSTED ON 3/3/2025
AVAILABLE BEFORE 6/2/2025

Job Description

Job Description

MBS is hiring a Quality Engineer in Walton, KY. This position is a full-time, Direct Hire opportunity.

FULL JOB DESCRIPTION

PRINCIPAL DUTIES & RESPONSIBILITIES

  • Contributes to the design and development of complex new products with an emphasis around ensuring design control (ISO 13485) and risk mitigation (ISO 14971) standards are met in line with company policies and procedures.
  • Formulates procedures, specifications, and standards for products and processes.
  • Participates in Team Meetings under Project Leader with cross-functional team.
  • Determination and validation of inspection methods.
  • Supports manufacturing and manufacturing engineering in the validation of suppliers and processes.
  • Development of work instructions, device master records, test and inspection methods and visual standards.
  • Reviews and approval of documents created within team.
  • Identifies critical personnel, gauges, procedures, and materials needed for the qualification of new products.
  • Creates production reports, manages supplier assessment and approved supplier lists (ASL) & creates audit plans.
  • Manages the nonconformance process (customer, internal, supplier) which includes trend analysis, corrective and preventive actions for assigned products or product families.
  • Ensures that suppliers have necessary information and facilities to deliver quality products meeting specifications.
  • Manages quality aspects of projects, as required (timelines, prototypes, testing, suppliers, etc.).
  • Contributes to cross-functional project teams to support all quality deliverables for design and development.
  • Drives problem solving of product quality design and process related issues from product development through release and including quality-related product sustaining activities.
  • Communicates and works with manufacturing to ensure design manufacturability and proper Risk Assessment.
  • Meets with and works closely with the project manager and customer to ensure all requirements are defined and met.

REQUIREMENTS

  • Requires a bachelor’s degree in engineering in Mechanical or Biomedical Engineering or equivalent work experience.
  • A minimum of 5 years’ experience in product quality within the medical device industry is preferred.
  • Previous knowledge and experience in manufacturing processes of chemicals & plastics is preferred.
  • Computer skills including Microsoft Office and Manufacturing Management products.
  • Must be familiar with cGMP requirements.
  • Recommended to have experience with EPA, FDA regulations (i.e. 21 CFR 820, ISO 13485 : 2016 & 21 CFR 211).
  • ABOUT THE KABLE GROUP

    For over 50 years, The Kable Group has been committed to connecting candidates looking for reliable work opportunities with companies in need of workforce solutions. We leverage our expertise in core industries to ensure that the needs of our clients and our candidates alike are satisfied. Whether it’s a professional position, skilled labor need, or an education opportunity, The Kable Group’s suite of solutions caters to finding the right fit, every time.

    At the Kable Group, we do not just accept diversity — we celebrate it, we support it, and we thrive on it. Read our full diversity statement here.

    This job description is not intended to be all-inclusive and the employee will also perform other reasonably related business duties as assigned by the immediate supervisor and other management as required.

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