Quality Assurance Specialist

2 weeks ago

Norwalk, Ohio, United States NISSHA MEDICAL TECHNOLOG IES OHIO INC Full time

OVERVIEW:
This position exists to provide essential Quality Engineering support, ensuring adherence to the Quality System, regulatory standards, and the strategic objectives of NISSHA MEDICAL TECHNOLOGIES OHIO INC.

KEY RESPONSIBILITIES:
As a vital member of cross-functional teams, you will support various stages including product development, procurement, manufacturing, and service operations while representing the Quality Engineering discipline. Your primary duties will include:

  1. Completing assigned Quality Engineering tasks within designated timelines.
  2. Promoting awareness of Quality and Regulatory standards across the organization.
  3. Leading or contributing to the development and modification of processes and procedures.
  4. Utilizing statistical process control (SPC) methods to assess current processes and any changes.
  5. Innovating solutions to problems identified during team collaborations.
  6. Assisting in the implementation and maintenance of compliance with standards such as FDA and ISO13485.
  7. Training personnel on all facets of the Quality System and regulatory requirements.
  8. Applying Quality System requirements to processes, products, or services at the location.
  9. Providing support to manufacturing lines to resolve quality-related issues.
  10. Contributing to metrology and preventive maintenance initiatives.
  11. Supporting validation and verification strategies for both new and existing products and processes.
  12. Leading the creation and upkeep of Master Validation Plans.
  13. Participating in the CAPA process as necessary.
  14. Investigating escalated product complaints to determine root causes and ensure prompt customer feedback and resolution.
  15. Monitoring product and process performance metrics, acting on both positive and negative trends.
  16. Contributing to Material Review Board (MRB) efforts to ensure appropriate handling of non-conformances.
  17. Authoring and approving Quality System documentation, including change orders and related materials.
  18. Conducting internal, vendor, and process audits as scheduled.
  19. Collaborating with suppliers to address Quality concerns.
  20. Driving measurable improvements in Quality related to products, processes, and services.

QUALIFICATIONS:
To be successful in this role, candidates should possess:

  • A Bachelor's degree in an Engineering discipline or equivalent.
  • Three to eight years of relevant experience, preferably within the medical device sector focused on process and quality engineering.
  • Knowledge of basic mechanical testing and material properties.
  • Familiarity with metrology.
  • Understanding of U.S. FDA QSR requirements, including ISO 9001 and MDD 93/42.

Preferred qualifications include ASQ certifications such as Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA). Strong problem-solving skills, statistical and analytical abilities, and familiarity with Problem Solving Tools (e.g., Process Mapping, Histograms, FMEA, Risk Assessment) are essential for this position.

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