Sr Supplier Qual Engineer

Planet Pharma; Minneapolis (MN); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Planet Pharma is seeking a Technical Specialist in our career stream to advance R&D and tech initiatives with external suppliers. You will manage supplier qualification, ensure GMP and regulatory compliance, and collaborate with design and QA teams to deliver high-quality components.

Autonomy is emphasized as you lead audits, drive process improvements, and mentor colleagues while delivering projects from design to implementation in a regulated environment.

Formación

• Bachelor's degree and 4+ years of relevant experience in regulated environments.
• Experience with supplier qualification, GMP/quality standards, and PPAP processes is a plus.

Responsabilidades

• Supplier selection and support.
• Component qualification.
• Component documentation and performance data review.
• Develop auditing schedules to ensure GMP and quality standards.

Conocimientos

Regulated technical industry

Critical thinking

Communication/documentation

Experience with suppliers

Component qualification

PPAP process (MDT)

Educación

Bachelor's degree

Herramientas

MDT PPAP process

Descripción del empleo

Responsibilities

• 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.
• Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow the company to provide customers with the highest quality and reliable products.
• Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implements strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
• Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
• Defines Receiving Inspection requirements as required and associated test method validation for all internal Test Methods.

Additional Position Details From The Manager Below

• Can you please confirm your top 3 skill sets required? Regulated technical industry experience, critical thinking/problem solving, strong communication/documentation skills, experience working with suppliers, component qualification experience (a plus if they have experience with MDT's PPAP process specifically)
• Can you please confirm the 3 main responsibilities/day to day activities required for this role? Supplier selection and support, component qualification, component documentation and performance data review
• What products (if any) will this role support? Components used in brain, spinal cord, and pelvic stimulation products
• What is your target years of experience? 4 years experience required with Bach degree, targeting 5+ years exp
• When do you plan to start interviewing? Late August
• Will you be looking to hire and start ASAP or will the start date be delayed? ASAP
• Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)? Preferably on-site...but open to remote workers too

TECHNICAL SPECIALIST CAREER STREAM

An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, 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 R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.

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 in-depth 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 decision-making.

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 Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

• 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.