We are looking for a Supplier Quality Engineer for our client, who is a leading medical device manufacturer currently undergoing integration and remediation activities following a recent acquisition. To support these efforts, we are seeking a dedicated Supplier Quality with hands-on experience in supplier quality management within the medical device industry and a thorough understanding of failure investigation processes.

Job Title: Supplier Quality Engineer
Duration: 12 Months (W2 Contract)
Location: Danvers, MA
Industry: Medical Device Manufacturing

Key Responsibilities:

• Examine and validate NCRs associated with supplier-provided components to ensure compliance with company standards and regulatory requirements.
• Approve and complete the closeout process for each NCR, ensuring accurate documentation and adherence to timelines.
• Act as the primary point of contact with suppliers regarding quality issues, fostering proactive communication and collaboration to resolve non-conformances effectively.
• Work closely with suppliers to implement corrective actions and ensure they meet the company's quality and regulatory standards.
• Adhere to and enforce the company's QMS procedures to maintain consistent, compliant, and effective quality processes.
• Participate in quality reviews and support QMS audits, ensuring the integrity of processes impacting supplier quality.
• Maintain accurate and compliant documentation throughout all stages of the NCR review and approval process.
• Ensure all records align with GDP standards, meeting the regulatory requirements necessary for medical device documentation.
• Perform risk assessments for NCRs to identify potential impacts on product quality and patient safety, applying mitigation strategies as needed.
• Ensure the accuracy, reliability, and security of data used in quality assessments, with an emphasis on maintaining data integrity across all records.
• Review failure investigation reports from suppliers to ensure thorough root cause analysis and appropriate corrective action implementation.
• Validate supplier-provided corrective actions to confirm they effectively address the root cause and mitigate future risks.

Skills:

• Familiarity with ISO 13485 standards and FDA regulations applicable to medical devices.
• Experience with root cause analysis and failure investigation methodologies.
• Proven expertise in handling non-conformance reports (NCRs) and quality notifications (QNs), with experience in the review, approval, and closeout of quality-related issues.
• Strong experience working with suppliers to address and resolve quality issues.
• Ability to communicate effectively and professionally with external partners.
• Basic understanding of risk management practices as they apply to non-conformance and quality management processes.
• Familiarity with GDP standards essential for maintaining clear, accurate, and compliant documentation.

Education and Experience:

• Experience in the Medical Device Industry
• Minimum of 3-5 years of experience in a supplier quality engineering role, preferably within the medical device or similarly regulated industry.