The Role
Lead supplier quality activities for medical device/pharma components: qualify and audit suppliers, monitor parts through manufacturing, support NPD with quality compliance, define inspection/test methods, drive continuous improvement, and travel to contract manufacturers to resolve supplier issues.
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:
- 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 Medtronic 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 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 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.
- Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.
- For this position is key the availability to travel to visit external Contract Manufacturers and Suppliers
- Bachelor's degree required (or, for degrees earned outside the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A)).
- Minimum of 4 years of relevant experience
- Works independently under limited supervision to determine and develop approaches to solutions.
- Coaches and reviews the work of lower-level specialists; may manage projects and processes.
- May be responsible for entire projects or processes within the assigned job area.
- Contributes to the completion of work group objectives by building relationships and consensus to reach agreements on assignments.
- Demonstrates the ability to solve difficult problems requiring an understanding of multiple issues, job areas, or specialties.
- Makes improvements to processes, systems, or products to enhance job area performance.
- Provides in-depth analysis and recommendations for process improvements.
- Communicates effectively with senior internal and external customers and vendors.
- Exchanges information, ideas, issues, and status updates to achieve objectives and influence decision-making.
- May provide guidance, coaching, and training to employees within the job area.
- May manage projects, including delegating work and reviewing the work products of others.
- Possesses advanced knowledge of the job area through a combination of education and relevant experience.
- Practical knowledge of project management is preferred.
- Available for administrative shift
- Hybrid Type position
Skills Required
- Bachelor's degree (or equivalent per 8 C.F.R. § 214.2(h)(4)(iii)(A))
- Minimum of 4 years of relevant experience
- Knowledge of Good Manufacturing Practices (GMP) and applicable quality/regulatory standards
- Experience qualifying suppliers and conducting supplier audits
- Ability and availability to travel to external contract manufacturers and suppliers
- Practical knowledge of project management
- Ability to work independently, coach lower-level specialists, and manage projects
- Available for administrative shift and hybrid work arrangement
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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
