Job title: Quality Engineer II
Location: Raynham MA
Provides overall quality assurance and quality engineering leadership in the management of contract manufacturing suppliers, including Finished Good Medical Devices, Direct and Indirect Material/Service Suppliers which can impact production and/or sale of product.
You'll conduct day-to-day and strategic activities in the lifecycle management of suppliers. As a SQE3, you will establish clear expectations and collaborate with internal and external partners that lead to consistent, reliable, quality products and services.
• Participate in the selection, categorization and qualification of suppliers and associated processes.
• Add, remove and update quality system supplier information and ensure accurate supplier information on the Approved Supplier List.
• Establish and provide relevant information detailed in supplier quality agreements and supplier change agreements.
• Execute and document supplier non-conformance reports (NCRs), Supplier Corrective Action Requests (SCARs) and Corrective and Preventive Actions (CAPAs).
• Define and lead actions related with Supplier Change Requests.
• Lead and support supplier assessments and supplier audits for compliance to regulations, agreements, standards and documented processes.
• Guide the development and improve comprehensive measurement systems for the SQ program and supplier quality performance. The SQE3 may report on such metrics at Quality System management reviews.
• Lead the transfer and qualification of established manufacturing processes to new suppliers.
• Ensure systems to measure, assess risk and escalate quality events. Manage quality events to identify, bracket, correct, control and prevent defects.
• Lead and document internal supplier quality procedure change efforts. The SQE3 will adhere/comply with and utilize multifaceted industry and process excellence standards on an expert level, including good manufacturing practices (GMP), equipment engineering system (EES), international organization for standardization (ISO) and country/governmental regulations. FDA CFR Part 820 and ISO 13485 regulations/standards will be the focus.
• A Bachelor's Degree is required. A Degree in Engineering, Life Science, or related discipline is preferred.
• A minimum of 4 years of experience in a GMP and/or ISO regulated industry. Experience in the medical device and/or pharmaceutical industry is preferred.
• Knowledgeable in FDA and ISO regulations. FDA CFR Part 820 and/or ISO 13485 knowledge is preferred.
• Auditing background is preferred.
• Strong communication, partnership, and analytical skills are required.
• Strong in root cause analysis skills.
• Experience and/or knowledge with machining manufacturing processes and injection molding is preferred.
• Six Sigma, Lean, or ASQ Certification and trainings are preferred.
• Experience with manufacturing processes including, but not limited to, CNC Milling and Turning, Press Breaking and Punching, Assembly, Metal Laser Etch, Silk-Screen, and Metal Processing such as passivating, anodizing and heat treating.
• The position will require up to 20% travel.