Supplier Qual Engineer II - Exempt

• 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 cross-functional teams and external stakeholders.
• Proficiency in Microsoft Office Suite and quality management systems (QMS).
• Strong technical writing capability.
• Demonstrated track record of effectively influencing and negotiating with all levels of an organization and leading effective/successful change initiatives.
• Demonstrated knowledge and expertise in supply chain management and supplier development, stakeholder management, risk/issue management, and implementation planning.
• Knowledge of plant operations preferred.
• Design Control knowledge preferred.
• Knowledge of sterilization methods preferred.
• Thorough understanding of US and international regulatory and quality assurance requirements associated with the development and manufacture of medical devices or drug products.
• Electronics Qualification/Experience would be an advantage.
• Working knowledge of inspection and test techniques, quality assurance procedures, statistical analysis, product usage, and device regulations.
• Knowledge of Quality System Regulations (QSR) and ISO requirements.
• Ability to budget for future expenditures and manage departmental budget.
• Ability to prepare and execute effective presentations to others.
• ISO 13485:2003 Certified Lead Auditor.
• 6 Sigma and/or Lean experience preferred (trained or certified).

LanceSoft