The Role
Ensures suppliers deliver compliant, high-quality parts, materials, and services for medical device manufacturing. Responsibilities include supplier qualification and evaluation, supplier performance monitoring, issue resolution, receiving inspection requirements, product acceptance sampling strategies, approved supplier coordination, control plans, test method validation, and quality improvements across the product lifecycle. Collaborates with R&D, sourcing, engineering, operations, and quality teams while ensuring compliance with industry standards, regulatory requirements, and customer expectations.
Summary Generated by Built In
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
Responsibilities:
- Responsibilities may include the following and other duties may be assigned.
- Ensures that suppliers deliver quality parts, materials, and services.
- Qualifies suppliers acco rding 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.
- Evaluates suppliers' internal functions to assess their overall performance and provides feedbackn in assessment of their operation.
- Partners with cross functional teams (R&D, sourcing, engineering, operations, quality), to deliver quality parts, materials, and services, prevent defects, and allow MiniMed to provide customers with the highest quality and reliable products.
- Provides technical guidance and quality compliance throughout the product lifecycle (with focuson supplier changes) and implementing 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 cross functional teams to develop and deliver the Product Acceptance
- Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and
- Control Plans for new products.
- Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.
- Required skills in order to successfully perform this role
- Bachelor’s degree in related area
- 4 years of relevant experience, or an advanced degree with a minimum of 2 years relevant experience.
- Requires advanced knowledge of job area combining breadth and depth, typically obtained
through advanced education combined with experience. - Demonstrated experience on Medical Device Industry or Automotive part qualification
- requirements
- May have practical knowledge of project management.
- Experience using Agile and Trackwise would be a plus
- Knowledge of ISO 13485 requirements
Skills Required
- Bachelor's degree in a related area
- Four years of relevant experience, or an advanced degree with at least two years of relevant experience
- Advanced knowledge of the job area gained through education and experience
- Experience with medical device industry or automotive part qualification requirements
- Practical knowledge of project management
- Experience using Agile
- Experience using TrackWise
- Knowledge of ISO 13485 requirements
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
