Responsibilities:  The Supplier Quality Engineer is responsible for 1) the qualification, evaluation, and routine monitoring of the organization’s suppliers of raw materials, components, purchased finished goods, contractors, and consultants; 2) the development, establishment and implementation of best-practice supplier quality engineering methodologies, processes, and practices; and 3) the development and fostering of strong collaborative relationships with the organization’s suppliers and company internal stakeholders to ensure purchased product meets quality, regulatory, and business needs.  Must be able to travel 33-50%, both domestically and internationally, as needed, sometimes on short notice.

 

Job Duties:

·       Lead and manage supplier qualification, including the early involvement of suppliers in product development

·       Develop supplier quality agreements

·       Ensure suppliers meet quality, regulatory, and business requirements

·       Develop and Execute validation protocols and First Article Inspection (FAI) and (PPAP) Production Part Approval Process

·       Facilitate the handling of supplier quality issues through execution of Supplier Corrective Action Request (SCAR) process

·       Develop and deploy supplier routine monitoring and assessment (KPIs)

·       Facilitate supplier quality improvement through the coordination of off-site and on-site (supplier) of continuous improvement activities with suppliers and internal stakeholders to improve quality, regulatory compliance, yield, and cost of purchased product

• Develop and ensure execution of the annual supplier audit plan

• Perform on-site and off-site audits to assess supplier’s Quality Management Systems (QMS) and its processes for effectiveness and efficiency
• Promote an “audit ready” culture within the supplier management function
• Assist in the execution of Quality Internal Audit Plans

 

Education/Qualifications/Experience:

·       Bachelor’s of Science degree in a scientific discipline (i.e. Biomedical, Chemistry, or Engineering)

·       Five (5+) years of experience in a quality assurance-related function in the biomedical industry, including direct experience in dealing with suppliers of purchased product (raw materials, components, finished product, and contractors/consultants

·       Experience in working with a QMS based on ISO 13485, 14971, and 21 CFR Part 820 in a light to moderate manufacturing environment, including both manual and equipment/machine-based processing

·       Quality auditing (external/supplier and internal) experience and certification (i.e. ASQ CQA or CBA, or other international certification body)

·       Developing and deploying Supplier Quality Metrics/KPIs

·       Medical Device Records, including Device Master Records, Risk Management Records and Device History File (DHF) maintenance

·       FMEA (Failure Mode and Effects Analysis)

 

Skills/Knowledge:

·       Technical writing skills

·       Verbal communication skills

·       Critical thinking and ability to evaluate risk in order to assume informed risk

·       Attention to detail

·       Ability to be assertive and work well with other; foster collaboration, teamwork and transparent communication with others, locally and globally

·       Results-oriented and able to work across the organization to achieve results; ability to influence others while not in a position of authority

·       Problem solving and root cause analysis skills

·       Ability to adapt to changing business needs and flexible when required to achieve results

·       Application of continuous Improvement tools and techniques (i.e. Six Sigma Green Belt or Black Belt, Lean Manufacturing)

·       Data analysis and basic statistics skills including Statistical Process Control (SPC)

·       PC skills, including Microsoft Word, Excel, PowerPoint, Outlook, and Teams

·       Basic project management skills