Sr Supplier Qual Engineer Remote at Medtronic

Ponce, Ponce, Puerto Rico

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience
Nice to have: Four years experience managing and owning Supplier Changes Management of 1st tier and sub tier supplier changes
Nice to have: Engineering assessment
Nice to have: Engineering Test Report (ETR)
Nice to have: Four years experience managing Molding supplier process validations
Nice to have: Production Part Approval Process (PPAP)
Nice to have: Manufacturing Impact Management

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
Collaborates with local SQEs to develop Product Service Segmentation (PSS), validation plan, complete change implementation activities and supplier audit scheduling
Reviews and approves supplier validation documentation to ensure good manufacturing practices (GMP) and quality standards are met
Works 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
Leads and works with multi-disciplinary teams, managing work through multiple time zones, which includes Sterilization, Microbiology, Biocompatibility and Manufacturing functions
Ensures Receiving Inspection requirements are met when executing change control
Collaborates with Molding & Capital Tooling to validate new molds and mold refurbishments through Production Part Approval Process, providing Quality technical guidance and approval
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
Some individuals may have responsibilities that include Pre-Market Supplier Quality: 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
Defines Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods

Skills

Supplier Qualification

GMP

Supplier Auditing

Validation Documentation

Production Part Approval Process

Change Control

Receiving Inspection

Sterilization

Microbiology

Biocompatibility

Molding Validation

Capital Tooling

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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