Orbis Clinical is seeking a Supplier Quality Engineer located in Waltham, MA (Hybrid 3x/wk) for 6 months.

Job Title: Supplier Quality Engineer

Location: Hybrid (3x/wk Waltham, MA) (occasional travel to the Marlborough, MA site)

Contract: 6 months

Summary:

We are seeking a Supplier Quality Engineer to join our growing Supplier Quality team. You will a key role in ensuring the quality, compliance, and performance of company's global supplier base. This is an opportunity to contribute to meaningful work on cutting-edge projects in a fast-paced, collaborative environment. You will be part of a cross-functional team of 3 highly motivated and collaborative professionals responsible for managing supplier qualification, risk mitigation, and quality performance. The team plays a key role in driving supplier accountability, supporting root cause investigations, and ensuring company's supplier network meets regulatory and quality standards. This role is based in Waltham, MA, and will report to the Senior Manager of Supplier Quality

Responsibilities:

The Supplier Quality Engineer (SQE) will be responsible for ensuring that company's suppliers meet all quality standards, regulatory requirements, and internal specifications. This role combines engineering expertise with auditing skills to oversee supplier performance, conduct audits, and drive continuous improvement initiatives. The SQE will work closely with suppliers to resolve quality issues, implement corrective actions, and develop strategies for risk mitigation.

Key Responsibilities:

• Support supplier development programs by identifying capability gaps and enabling continuous improvement plans with key and critical suppliers. Partner with Sourcing to align on strategic supplier performance.
• Supplier Change Notifications (SCNs): Evaluate and manage Supplier Change Notifications, ensuring that all changes are documented, reviewed, and analyzed for impact on quality and compliance. Coordinate cross-functional review teams to assess the potential risks of supplier changes.
• Supplier Qualifications: Conduct technical evaluations and qualifications for new and existing suppliers. This includes reviewing supplier manufacturing processes, capabilities, and compliance with company's engineering and quality requirements.
• Supplier Corrective Action Requests (SCARs): Initiate and manage SCARs to address non-conformances identified during audits or routine quality checks. Work with suppliers to implement effective corrective and preventive actions, conducting follow-up audits to verify the effectiveness of actions taken. Standardize and drive accountability in SCAR closure timelines and root cause quality. Implement risk-based SCAR prioritization to ensure critical issues receive senior-level supplier attention. Collaborate with Procurement to reinforce supplier performance expectations.

Non-Conformance Material Reports (NCMRs):

• Manage the NCMR process, ensuring timely identification, documentation, and resolution of non-conforming materials from suppliers. Collaborate with suppliers to investigate root causes and implement corrective actions to prevent reoccurrence.  Lead efforts to reduce repeat NCMRs through trend analysis, supplier feedback loops, and CAPA integration. Coordinate with internal teams to ensure timely disposition of materials and closeout of NCMRs. Own the escalation process for high-risk or recurring NCMRs with Procurement and Supplier Quality leadership.
• Supplier Performance and Scorecards: Develop and maintain supplier scorecards to monitor performance on key metrics, including quality, delivery, cost, and service. Collaborate with suppliers to identify areas of improvement based on performance trends.

Approved Supplier List (ASL) Maintenance:

• Ensure that company's Approved Supplier List (ASL) is regularly updated to reflect current supplier status. Work cross-functionally to qualify and requalify suppliers based on quality performance and audit results.
• Conduct Supplier Audits: Plan and perform on-site and remote audits of suppliers to evaluate their quality management systems, production processes, and adherence to engineering specifications. Provide detailed audit reports, including risk assessments and recommendations for improvement.
• Conduct Risk Assessments: Perform supplier risk assessments to evaluate the likelihood and impact of potential risks to quality, regulatory compliance, and supply chain reliability. Develop and monitor risk mitigation strategies, especially for high-risk suppliers.
• Continuous Improvement Initiatives: Partner with suppliers to drive continuous improvement in quality, cost, and delivery. Use root cause analysis, statistical tools, and engineering methods to help suppliers optimize their processes and products.
• Product and Process Validation: Assist in the validation of supplier processes and products, including first article inspections, process capability studies, and engineering evaluations. Ensure that all supplier-provided materials and components meet company's technical and quality specifications.
• Compliance with Regulatory Standards: Ensure supplier adherence to industry regulations (FDA, GMP, etc.) and maintain up-to-date knowledge of applicable regulatory and quality standards. Collaborate with the internal compliance team to align supplier practices with company's regulatory obligations.
• Act as a liaison between Quality, Procurement, Engineering, and Regulatory functions to ensure cohesive supplier strategies and decisions.

Education and/or Work Experience Requirements:

• Bachelor’s degree in engineering, Quality, or related technical field.
• 7+ years of experience in supplier quality engineering, manufacturing engineering, or quality assurance.
• Supplier QMS & Process auditing experience (ISO 9001)
• Strong problem-solving skills, including root cause analysis and corrective action methodologies.
• Proficiency in conducting risk assessments and quality audits.
• Experience with eQMS systems or digital audit tools
• Familiarity with regulatory standards (FDA, GMP, etc.).
• Excellent communication, negotiation, and interpersonal skills.
• Willingness to travel for supplier audits and evaluations.

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $64.51 - $68.96 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). 

EEO and Reasonable Accommodation Statement:

Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.