Sr. Quality Engineer- Validation

Medtronic • Juncos, PR

1d

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life The Senior Quality Engineer is responsible for managing the site validation program and providing quality engineering support for laboratory operations, special quality improvement projects, and day-to-day quality activities. This role ensures compliance with applicable regulatory requirements, including FDA, ISO, and cGMP standards, while supporting operational excellence and continuous improvement initiatives across the organization. The position serves as a subject matter expert in validation lifecycle management, quality systems, and laboratory support while collaborating cross-functionally with Manufacturing, Engineering, R&D, and Quality teams. Responsibilities may include the following and other duties may be assigned.

Requirements

• Requires a bachelor’s degree in engineering 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.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

• Preferred Skills Strong knowledge of: Validation lifecycle (IQ/OQ/PQ), cGMP regulations, Risk management, Root cause analysis methodologies, Quality systems (CAPA, deviations, change control).
• Experience supporting laboratory environments and analytical testing preferred.
• Strong problem-solving and analytical skills
• Ability to lead cross-functional initiatives
• Effective communication and technical writing skills
• Attention to detail and regulatory compliance mindset
• Ability to manage multiple priorities in a dynamic environment

Responsibilities

• Ensure validation activities comply with cGMP, FDA regulations, ISO standards, and internal quality procedures.
• Develop, review, and approve validation documentation including Validation plans, Protocols (IQ, OQ, PQ), reports and summary documents
• Support lifecycle management of validated systems, including requalification, change control, and periodic review.
• Provide guidance on risk-based validation strategies aligned with industry standards (e.g., GAMP, ICH Q9).
• Provide quality engineering support to analytical laboratories.
• Assist with method validation/verification and troubleshooting activities.
• Support laboratory equipment qualification and lifecycle management.
• Lead or participate in cross-functional quality improvement projects.
• Drive initiatives related to process optimization, validation efficiency, and quality system improvements.
• Support implementation of new technologies, automation, or process changes requiring validation oversight.
• Provide technical expertise during new product introduction (NPI) or process transfer activities.
• Provide day-to-day quality engineering support to operations.
• Support deviation investigations, CAPA development, and root cause analysis.
• Participate in change control assessments, ensuring proper validation impact evaluation.
• Review and approve technical documentation related to manufacturing and quality systems.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level