Jobs for People with MS: National MS Society

Description

Job Title: Quality Assurance Engineer Associate – Supplier Quality Engineer

Employment Type: Contract (Potential Extension)

Job Location: Batesville, IN

Job Description:

We are seeking a motivated and detail-oriented Quality Assurance Engineer II (Supplier Quality Engineer) to join our team. This role will focus on ensuring quality and regulatory compliance for purchased components and supplier relationships within the manufacturing environment of medical bed devices. The ideal candidate will support various quality engineering functions while driving continuous improvement initiatives in alignment with regulatory standards and company policies.

Key Responsibilities:

• Act as the primary point of contact for quality-related matters concerning medical bed devices.

• Drive improvements in the quality system and ensure compliance with regulatory and procedural requirements.

• Collaborate with suppliers, engineering teams, and quality organizations to address product functionality, quality, and regulatory compliance issues.

• Partner with design engineering to establish receiving inspection requirements for purchased components and finished products. Provide technical support to receiving inspection operations.

• Assist operations teams with troubleshooting non-conformities related to part defects.

• Participate in external and internal regulatory compliance audits or inspections.

• Assist in the development, review, and approval of supplier process and equipment validations/qualifications (IQ, OQ, PQ).

• Contribute to corrective action system activities, including evaluating failure investigations, corrective action plans, root cause analysis, and follow-up initiatives.

• Lead Health Hazard Evaluation (HHE) activities for assigned areas.

• Define, implement, and oversee key controls and metrics to ensure operational excellence.

• Ensure the efficient and timely processing of quality records, maintaining compliance with 21 CFR 820 regulations.

• Collect, analyze, and track supplier performance data while monitoring key metrics in collaboration with cross-functional teams.

• Develop and deliver training to ensure the proper implementation of quality tools and procedures.

  Requirements

Qualifications:

• Strong understanding of quality systems and regulatory compliance standards for medical devices (21 CFR 820).

• Proficient in quality assurance practices, risk analysis, and data-driven decision-making.

• Demonstrated ability to troubleshoot and resolve quality issues with suppliers and internal departments.

• Experience with supplier validation processes, receiving inspection protocols, and corrective action planning.

• Effective communication and collaboration skills to build productive relationships with stakeholders.

Preferred Skills (Optional):

• Knowledge of Health Hazard Evaluations (HHE) processes.

• Familiarity with equipment qualifications such as IQ, OQ, PQ.

If you are an analytical thinker who thrives on solving challenges and fostering quality-driven partnerships, we encourage you to apply for this exciting opportunity.

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