Associate Quality Project Manager
Associate Quality Project Manager - 40975
Description Purpose/Role Statement An Associate Project Manager is responsible for assuring all requirements of the Product Development Process (PDP), Design Controls and External Manufacturer Production Controls are met by: a) Supporting or facilitating Corporate Quality initiatives utilizing their PDP, and quality systems and project management expertise b) Leading project teams to decisions and deliverables associated with quality and compliance (e.g. Product Specification, Design Review, Design VV, SW Validation, Test Methods, Process Validation, Labeling) whether internal, co-developed or externally manufactured c) Facilitating the execution of Quality deliverables such as Risk Management, Design FMEA, Quality Plans, and Field Assessment Plans d) Facilitating and coaching for post market product sustaining activities, such as design changes, supplier auditing and surveillance, design concessions, product marking and safety certification, customer complaints, PIR?s and CAPA?s Key Responsibilities · Champions 100% compliance to Company Policy and SOP?s · Devise and support the implementation of effective quality assurance, process controls, statistical analyses and metrics that assure products meet or exceed internal quality as well as statutory requirements · Apply sound, systematic problem solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues · Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Design FMEA, Project Quality Plan, Field Assessment Plan, Risk Management Plan, Software Validation Plan) · Provide quality and statutory guidance as needed to assure country specific compliance to the laws and regulations of the targeted market for distribution · Provide quality and statutory guidance to Sustaining Engineering in support of post market design changes, including assessment with respect to Design Controls and PDP scaling requirements · Lead the project team or sustaining engineering whenever course of actions are proposed that could jeopardize FDA QSR or ISO compliance · Assure performance of thorough complaint investigations within the statutory and corporate time constraints · Provide product specific supplier and co-development quality assurance expertise during supplier audits, and through approval of supplier PDP and Design Controls deliverables · Measure and oversee the real-time continued quality of internal and external Component and Finished Good Suppliers · Provide key quality trending information and data for Management Review Qualifications · BS/BA in Engineering and/or Science Related discipline and/or equivalent combination of education and experience · 5-7 years experience in a Quality role, preferably in medical device or related field · 5-7 years experience in Medical Device and/or equivalent field. Solid background in QSR and MDD Quality System requirements. · Proficiency in MS-Office (Word, Excel, PowerPoint, Project, Visio) · Able to communicate at all organizational levels both within BSC and with outside companies · Able to work well in a team environment with peer group