Senior Supplier Quality Engineer

Key Responsibilities

• Lead and facilitate problem-solving activities with suppliers using methodologies like 8D, 5Why, and Ishikawa diagrams to implement effective corrective and preventive actions (CAPA).
• Lead supplier quality improvement teams, manage supplier yield/data reporting, and ensure continuous improvement of quality and efficiency of external manufacturing operations.
• Lead supplier quality review meetings to ensure follow-up of issues and implementation of Corrective and Preventative actions.
• Perform supplier and internal audits for ISO 13485 and ISO 9001 and develop corresponding audit reports.
• Support the achievement of key site metrics, such as complaint reduction, by leading Engineering Change Requests related to manufacturing specifications, drawings, and procedures, and by providing technical assistance to resolve customer complaints and chronic supplier issues.
• Develop qualification and validation documentation to support changes to existing products and/or processes.
• Collaborate and develop Incoming Quality requirements and Statistical analysis of incoming and Supplier process data.
• Drive continuous improvement initiatives to enhance performance, quality and efficiency of external suppliers.
• Support of the new product introduction process.
• Manage change control and replacement due to obsolescence of components.

Minimum Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or other Engineering discipline.
• 3+ years of work experience in quality assurance or quality engineering role within supplier management in the biotechnology industry.
• 1+ years of work experience in Supplier Quality Management.
• Excellent oral and written communication skills.
• Practical knowledge of stainless steel machining, Nickle Plating passivation, media/filters, chemicals, O-rings/gaskets, and Mixer motors and control boxes, Plastic welding gained through 3+ years of work experience is a plus.
• Demonstrated ability to perform failure analysis of customer complaints gained through 1+ years of work experience.
• Excellent analytical, problem-solving and decision-making skills; self-directed and self-motivated with excellent organizational skills with ability to prioritize and work effectively on multiple tasks with varying requirements and deadlines.
• Create, review, and approve Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Master Validation Plans (MVP), and Product Validations (PV) gained through at least 1+ years of work experience.

Preferred Qualifications

• Master’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or other Engineering discipline and 1+ years of experience in process/quality engineering and supplier management in biotechnology industry.
• TrackWise, SAP, Oracle, ManGo, Veeva experience is a plus.
• Knowledge of current ISO and cGMP standards and lead audit experience for supplier and internal audit gained through 1+ years of work experience.
• Experience with new product introduction and buy/resell processes is a plus.
• Experience managing Mechanical suppliers is a plus.

Pay Range

Pay Range for this position: $104,300 - $188,000

Benefits

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses.

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