General Characteristics:
Uses standard supplier management techniques and quality engineering principles to monitor and improve supplier performance. Works with R&D, Manufacturing Engineering, Purchasing, and Incoming Quality to resolve supplier quality and documentation issues. Minimal supervision that is commensurate with prior experience, demonstrated ability, and importance or complexity of the task at hand. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
Essential Job Responsibilities:
· Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for the incumbent's position and documenting that training).
· Ensures that supplier performance is monitored in a way that conforms to corporate and divisional requirements.
· Tracks supplier performance using appropriate databases for the purposes of identifying and prioritizing material and supplier issues and demonstrating their resolution. Creates new databases as necessary to improve and simplify these activities.
· Develops and prioritizes and conducts supplier site and mail-in audits using personal, department, company, and corporate resources as necessary. As needed assists suppliers in understanding and developing quality systems that meets corporate and divisional requirements and ensures that quality products are produced and delivered by suppliers.
· Prioritizes and selects suppliers for participation in supplied data programs based on internal and external priorities and needs and supplier capabilities. Identifies and helps resolve problems and conflicts.
· Works directly with suppliers as necessary to resolve quality issues. Enlists support from internal, company personnel and departments as needed to accomplish this. Conducts source and first article inspections and/or coordinates them with Manufacturing Engineering, R&D, and IQC.
· Collects, collates, and reports on data generated for the purpose of qualifying suppliers for the supplied data program, including such activities as first article inspections and test method alignment.
· Works with Incoming Quality and other departmental resources to identify and resolve incoming quality problems associated with internal, documentation, or specification issues not specifically assignable to suppliers.
· Works with R&D and Manufacturing Engineering to ensure that incoming product specifications contain and clearly communicate the requirements needed to ensure the part or material fulfills it role in the finished product.
Non-Essential Job Responsibilities:
· Assists Incoming Quality in resolving internal and external audit findings and observations, MRR’s, CAR’s and VCAR’s as needed and necessary.
· Assists R&D, Manufacturing Engineering, Quality Assurance Engineering, and Quality Assurance in understanding supplier capabilities and issues and in resolving problems associated with incoming material use. Based on knowledge, acts as the supplier’s internal spokesperson.
· Undertakes special assignments at the direction of the Supplier and Incoming Quality Manager.
· Develops SLP, SOP, and IQC documents and modifies existing ES and SU documents for the purpose of improving processes and quality or correcting errors. Initiates ECO’s as necessary.
· Works with R&D and Purchasing to evaluate new suppliers and their capabilities.
· Functions as an internal quality consultant as needed and necessary, commensurate with the individual’s training, experience, and knowledge.
· Performs responsibilities required by the Quality System and other duties as assigned or requested.
Position Qualifications
Associate Degree (Bachelor Degree preferred) in Science or Engineering related fields. ASQ certification (CMI, CQT, CQE, CRE). 3-5+years in a similar position or experience/knowledge of inspection methods and varied production processes. Knowledge of QSR’s and computer literacy required. Must be familiar with statistical techniques and have experience working in a manufacturing environment. Strong technical, organization, and verbal communication skills. Prior experience working in the medical device industrdf-dg |
