Sr Supplier Qual Engineer

2 days ago

Mounds View, United States LanceSoft Full time

Must Have:
Demonstrated working knowledge of supplier controls, process validation, supplier and internal auditing, failure investigation techniques, statistical quality control, protocol/report preparation and non-conforming product controls Manufacturing processes or R&D experience

JOB DESCRIPTION
Additional position detail from the manager below:
This role of pre-market Supplier Quality Engineering will directly be the key partner for selected development projects up to product launch.

Can you please confirm your top 3 skills sets required?
Supplier Management and Supplier Controls knowledge to develop supplier controls and qualification plans and reports to assure components, materials and suppliers meet specified requirements and performance, reliability goals.
High Technical Rigor, review and approve changes to *** specifications and review and approve supplier changes.
Develop technical solutions to complex problems using the corrective/preventative action.
Can you please confirm the 3 main responsibilities/day to day activities required for this role?
Support the evaluation and selection of global best-in-class components suppliers/ CM/OEM through the application of appropriate tools and measurements
Partner with multiple functions, including Supplier Quality, Design Engineering, Manufacturing, Quality, Reliability and Regulatory to evaluate, select and approve component or materials for active projects.
Partner with suppliers to ensure components / materials / sub-assemblies are qualified and validated to the appropriate requirements prior to commercialization.
What products (if any) will this role support? As pre-market supplier quality, this role will support the New development process as SQE key partner. Will own different projects from early development phase up to post market transition. The support is across the CRM sites and/or Contract manufacturers.
What is your target years of experience? 4+ years of experience in quality or engineering, Nice to Have: 4+ years of supplier quality engineering experience in the medical device industry or related field with supplier quality management expertise.

When do you plan to start interviewing? ASAP there are candidates available
Will you be looking to hire and start ASAP or will the start date be delayed? Need to hire asap
Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)? Contingent to be based out of Mounds View, could be set up as both at least 3 days on-site are required or could be more depending on project requirements.

Would be essential to have knowledge of supplier controls, process validation, supplier and internal auditing, failure investigation techniques, statistical quality control, protocol/report preparation and non-conforming product controls Manufacturing processes or R&D experience.
Some of this main responsibilities may include but not limited to the following:
- Review and approve changes to *** specifications for purchased materials
- Develop and maintain controls and qualification plans and reports
- Review and approve supplier change requests and partner with Sourcing Engineering to develop and implement appropriate strategies to qualify and support the change approval process
- Develop technical solutions to complex problems using the corrective/preventative action process
- Analyze and identify trends from quality data
- Lead or participate in supplier audit/assessment of current or future suppliers

Responsibilities may include the following and other duties may be assigned. Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

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