Responsibilities:
- Increase of volume of SQ activities related to business growth, increase capacity to supplier base, qualification of new tooling, and yield improvement efforts.
- 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.
- Evaluates suppliers' internal functions to assess their overall performance and provides feedback 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 client to provide customers with the highest quality and reliable products.
- Provides technical guidance and quality compliance throughout the product lifecycle, with focus on supplier changes, and implements strategies for driving product quality and continuous improvement.
- Ensures purchased products and components are manufactured and qualified in accordance with applicable industry standards, regulatory requirements, and customer requirements.
- Collaborates with cross functional teams to develop and deliver:
- Product Acceptance Sampling Strategy
- Approved Supplier List coordination
- Supplier Owned Quality deployment
- Control Plans for new products
- Defines Receiving Inspection requirements as required.
- Supports associated test method validation for all internal Medtronic Test Methods.
- Bachelor’s degree in related area
- 4 years of relevant experience, or an advanced degree with a minimum of 2 years relevant experience.
- Demonstrated experience in Medical Device Industry
- May have practical knowledge of project management.
- Experience using Agile and Trackwise would be a plus.
- Knowledge of ISO 13485 requirements.
- Knowledge of FDA QMSR.
- Knowledge of Geometric Tolerances.
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
- Demonstrated experience in the medical device industry
- Knowledge of ISO 13485 requirements
- Knowledge of FDA QMSR
- Knowledge of geometric tolerances
- Practical knowledge of project management
- Experience using Agile and TrackWise
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
