Supplier Qual Engineer II - Exempt

Contract Manufacturer Quality Manager

The role is responsible for managing finished goods Contract Manufactured (CM) for Robotics Surgical Technologies. Primary duties focus on all Quality Management System (QMS) related matters, including supplier selection, processing supplier change requests, qualification, manufacturing, QMS development, and technical quality/service/cost improvements.

• APQP/FMEA
• APQP/PPAP Practitioner
• Develop control plans
• SCAPA

• Lead, support, review, and approve supplier change requests (SCR), Validation, TMV, PPAP, CAPA, QMS, etc.
• Work with new and existing clients/suppliers to develop, implement, and maintain technical quality assurance systems and activities, including Quality Plans, Control Plans, and FMEAs.
• Familiarity with medical industry requirements such as ISO 13485, 21 CFR 820 standards, etc.
• Represent the supplier quality engineering function to develop and execute the strategy to organize, direct, and report on all CM quality-related activities for contracted design and manufactured items.
• Lead PPAP qualifications with the client.
• Collaborate with clients to develop robust SCAPAs.
• Support the Quality team to develop and improve an effective Supplier Quality process that supports finished goods product quality globally.
• Develop, implement, and monitor client/supplier's development initiatives, including CM performance management, CM certification, process improvements, cost reduction, supplier forums, Six Sigma/Lean integration, audits, and selection activities.
• Collaborate on New Product Development (NPD) teams to evaluate and understand future client needs and their associated quality and development plans.
• Build and own the strategy for managing the client/suppliers for the business.
• Communicate with the business Quality lead on CM initiatives, updates, and issues.
• Ensure CM compliance with business Quality Systems and all relevant internal procedures and policies.
• Facilitate customer complaints for CM products and ensure adequate investigation and corrective actions are taken by the client.
• Manage Supplier Corrective Action Request program to ensure consistency in handling corrective actions by the client.
• Develop, communicate, and manage a strategy/plan for addressing finished goods client/suppliers capability deficiencies.
• Ensure proper approval and documentation practices are followed for any process, material, or tooling change (SCR – Supplier Change Request) at the client.
• Define and manage the process for growing effective "partnerships" with preferred clients to drive optimal performance.
• Lead by example:
  Setting a continuous-improvement driven mentality and solid quality culture for the organization.
• Maintain compliance to set Key Performance Indicators for the business.
• Manage and report on client/suppliers audit program in line with ISO and/or FDA 21 CFR part 820 regulations.
• Translate engineering, manufacturing, and quality requirements for CM products.
• Perform deviation investigations into quality issues arising from CM activities.
• Manage qualifications of changes and coordinate associated change control activities.
• Evaluate clients using the appropriate CM performance management processes and develop reports on CM quality performance for company management.
• Responsible for ensuring that effective up-to-date CM Quality Assurance documentation, procedures, and specifications are maintained.
• Participate in annual supplier forums and business reviews.

• 10 years of experience in the medical device industry, with a strong background in field corrective actions, CAPA, or product quality management.
• Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
• Proven experience leading FCA and CAPA processes, ideally within a medical device or regulated industry.
• Strong project management skills, with the ability to manage multiple priorities and deadlines.
• Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.
• Outstanding communication and interpersonal skills, capable of effectively working with…