We are seeking an experienced, high caliber Supplier Development Quality Engineer. The Supplier Development Quality Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet SJM and regulatory requirements.
Each employee can make a difference at St. Jude Medical and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
Impact this role will have on St. Jude Medical:
* Contributes to the development, maintenance and improvement of SJM supplier development quality program policies, procedures and forms.
* Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements.
* Reviews and approves all supplied product drawings and component quality plans.
* Manages development of supplied product inspection procedures and first article requirements.
* Provides engineering guidance to SJM Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures.
* Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits.
* Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests and technical discussions.
* Participates and provides engineering ownership for all supplied product Non-Conforming Material Reviews.
* Contributes and participates in supplier performance reviews.
* Evaluates and develops Supplied Data Agreement, Skip Lot, Dock-to-Stock, CoC, and CoA partnerships with suppliers.
* Applies sound engineering analysis and judgment to reduce the need for inspection in accordance to program policies.
* Works with Manufacturing engineering to assess and address purchased product issues.
* Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
* Design and conduct experiments for process optimization and/or improvement
* Participate in or lead teams in supporting Supplier Development Quality program requirements (e.g., represent the Supplier Development Quality function as a Core Team Member)
* Mitigates SJM risk by working with the Suppliers to document Process Flow Charts, PFMEAs, and Control Plans.
* Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
* Performs other related duties and responsibilities, on occasion, as assigned.
Your experience(s), education and knowledge will further expand St. Jude Medical’s marketplace success:
* BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred.
* 2-5 years Medical Device and/or Engineering experience
* Engineering experience and demonstrated use of Quality tools/methodologies
* Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
* Solid communication and interpersonal skills
* Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
* Advanced computer skills, including statistical/data analysis and report writing skills
* Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
* Ability to work in a highly matrixed and geographically diverse business environment.
* Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
* Ability to leverage and/or engage others to accomplish projects.
* Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
* Multitasks, prioritizes and meets deadlines in timely manner.
* Strong organizational and follow-up skills, as well as attention to detail. Ability to maintain regular and predictable attendance.
* Ability to maintain regular and predictable attendance
Your preferred qualifications and education:
* Prior medical device experience preferred
* ASQ CQE or other certifications preferred
* Experience working in a broader enterprise/cross-division business unit model preferred.
**Job:** **EN-Quality Assurance Engineering*
**Title:** *Supplier Development Quality Engineer*
**Location:** *Minnesota-Plymouth*
**Requisition ID:** *150001BK*
↧