Supplier Qual Engineer II.

Careers that Change Lives

A Day in the Life

The Supplier Quality Engineer is responsible for managing finished goods at Contract Manufacturer (CM) for Robotic Surgical Technologies.

Primary duties are focused on part qualification (PPAP), process improvements, supplier change requests, and all QMS-related matters pertaining to selection, qualification, manufacturing, QMS development, and technical quality / service / cost improvements.

ESSENTIAL FUNCTIONS :

• 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 made for the business
• Lead PPAP qualifications with the CMs
• Collaborate with CMs to develop robust SCAPAs
• Support the Quality team (member of) to develop and improve an effective Supplier Quality process that supports finished goods product quality globally.
• Work with new and existing CMs / Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including MSAs, SPC, Quality Plans, Control Plans, and FMEAs
• Collaborate on New Product Development (NPD) teams to evaluate and understand future CMs and their associated quality and development plans
• Build and own the strategy for managing the CMs / Suppliers for the business
• Communicate with the business Quality lead on CM initiatives, updates, and issues
• Partner with Supplier Quality Managers to build a strategy for managing the CMs in all regions
• 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 CMs
• Manage Supplier Corrective Action Request program to ensure consistency in handling corrective actions by CMs
• Develop, communicate, and manage a strategy / plan for addressing finished goods CMs / Suppliers capability deficiencies, etc.
• Ensure proper approval and documentation practices are followed for any process, material or tooling change (SCR Supplier Change Request) at CMs
• Define and manage the process for growing effective "partnerships" with preferred CMs (to drive optimal performance) founded on common interest and which demonstrate trust, loyalty and financial success
• Maintain compliance to set Key Performance Indicators for the business
• Maintain the highest level of compliance and operational standards set by the business
• Manage and report on CMs / 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 co-ordinates associated change control activities
• Evaluate CMs using the appropriate CM performance management processes and develop reports on CM quality performance for company management, recommend and implement the continuous improvement of CM quality systems
• Responsible for ensuring that effective up-to-date CM Quality Assurance documentation, procedures, and specifications are maintained

OTHER FUNCTIONS :

• Participates in project teams associated with product, process or sourcing activities and improvements for contract-manufactured products
• Is the liaison between business and CM sites for the deployment and communication of needs and new or improved quality requirements
• Responsible for CM quality activities associated to sub-tier suppliers in the event of acquisitions and divestitures of CMs
• Evaluate purchased product performance as necessary and recommend and implements applicable improvements
• Participates on and assists teams and sourcing in making key CM product decisions that affect product performance
• Occasionally acts as a technical resource to other businesses, departments, CMs, and customers to address and resolve issues with purchased product
• Ensures statistical process tools are used effectively to reduce waste and product variability
• Works with internal auditors on audits or inspections required to be completed on the purchased product

DEPARTMENT SPECIFIC / NON-ESSENTIAL FUNCTIONS :

• Other duties as assigned with or without accommodation
• Maintains the professional competency, knowledge and skill necessary for the successful performance of assigned duties and responsibilities
• Demonstrates company advocacy in interaction with CMs

Experience :

• Minimum 3-5 years experience in a Supplier Quality, Quality Engineering Engineering function.
• 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, implementation planning, training / communication, scope management
• Knowledge of plant operations preferred
• Design Control knowledge preferred
• Knowledge of sterilization methods preferred
• Thorough understanding of the 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 requirement
• 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)

Must Have : Minimum Requirements

• Bachelors degree required
• Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

Nice to Have

• Expert in PPAP process and requirements
• Expert knowledge in corrective and preventive action (CAPA / SCAPA)
• High-level Supplier Change request knowledge
• Mastery of medical device quality systems and applications is required
• Demonstrated ability to work successfully in complex and emerging markets, leveraging interpersonal, communication, and technical skills to optimize results
• Self-starter, with the ability to work independently and with all levels of managers, associates, and clients
• Can effectively lead Change Management efforts
• Excellent oral / written communication skills
• Strong analytical and statistical problem-solving tools
• Mastery of software programs - Microsoft Word, PowerPoint, Excel, Project, Minitab
• Multilingual is a plus, English is a requirement

ORGANIZATIONAL RELATIONSHIPS / SCOPE :

• Works directly with Quality Management in development of a finished goods CM quality program
• Works with business Quality leads on communications and CM quality support
• Works with Quality Managers Contract Manufacturing (peers) to develop metrics, best practices, and common processes
• Works with Marketing on CM matters that affect product quality and availability
• Works with R&D or related Engineering team on CM quality for new product development
30+ days ago