Manager, Design Quality and Risk Management (Wayne, NJ)

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

We are seeking a Manager, Design Quality and Risk Management, to take on a role that blends Quality Engineering and Compliance responsibilities. This position plays a key part in supporting Design Controls and Risk Management activities throughout the product development lifecycle.

The position reports to the Wayne Getinge Headquarters and will have up to 4 direct reports.

Job Responsibilities and Essential Duties

• Establish and maintain robust design quality assurance processes and procedures to ensure compliance with regulatory requirements and industry standards throughout the product development lifecycle.
• Develop quality plans for new product development projects, outlining quality objectives, criteria, and methods for design verification and validation.
• Lead risk management activities during relevant product development phases, including risk assessment, mitigation strategies, and risk control measures to ensure product safety and efficacy.
• Oversee design verification and validation activities, including testing, analysis, and reviews, to ensure that design outputs meet design inputs and intended use requirements.
• Participate in Technical Design Reviews utilizing technical expertise with quality design practices (drawing standards, tolerance stack-ups, design weaknesses, appropriate design verification methods with appropriate statistics for the design, etc.)
• Conduct regular design reviews and audits to assess compliance with design controls, quality standards, and regulatory requirements. Identify opportunities for improvement and implement corrective actions as needed.
• Oversee Post Market Surveillance activities to ensure they are appropriately performed in a timely manner.
• Collaborate with cross-functional teams, including engineering, product management, regulatory affairs, and manufacturing, to ensure alignment on design quality objectives and requirements.
• Maintain accurate documentation of design quality assurance activities, including design history files, risk management files, and quality records. Prepare reports on design quality performance for management review.
• Provide training and guidance to design and engineering teams on design quality assurance processes, standards, and best practices.

Minimum Requirements

• Bachelor's degree in engineering, quality assurance, or equivalent combination of education and relevant experience required
• Master's degree preferred.
• Minimum of 10 years of experience in quality assurance or quality engineering roles, with a focus on design quality assurance in the medical device, pharmaceutical, or regulated industry.
• Proven experience managing others and influencing cross-functional teams
• Demonstrated ability to influence an organization's mindset/perspective to good engineering work with compliance through hands-on, teaching, coaching, mentoring.

• Proven experience navigating resistance, addressing organizational process gaps, and bridging fundamental challenges by building strong relationships, credibility, and trust
• Strong understanding of design control principles, regulatory requirements (e.g., FDA, ISO 13485), and industry standards (e.g., IEC 62304, ISO 14971).
• Six Sigma, Green Belt preferred.
• Experience with risk management methodologies (e.g., FMEA, fault tree analysis) and tools.
• Excellent analytical and problem-solving skills, with the ability to analyze complex issues and implement effective solutions.
• Strong project management skills, with the ability to manage multiple projects simultaneously and meet deadlines.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Detail-oriented with a focus on accuracy and precision.
• Certification in quality management (e.g., Certified Quality Manager, Certified Quality Engineer) is a plus.
• Proficient using in Microsoft Office Suite

The base salary for this position is a minimum of $140,000 and a maximum of $160,000 plus 15% annual bonus

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About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.