Manager Quality Engineering

1 week ago

Woburn, Massachusetts, United States J&J Family of Companies Full time
Manager, Quality Engineering W
Description
Abiomed, a part of Johnson& Johnson MedTech, is currently recruiting for a Manager, Quality Engineering. This position is based in Woburn, MA
At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at

Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives.

Abiomed's "Patients First" culture drives our skilled workforce and strong relationships with clinicians.

Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before.

Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.
Summary

Manages the day-to-day operations of the Quality Engineering staff at the Woburn facility of Abiomed (a Johnson & Johnson company).

Oversees the development and implementation of processes, procedures, audits and corrective actions for the manufacture of medical device components. Ensures effective communication and training are deployed throughout the business.
Job Description
Maintains quality records on product testing, nonconformance, project outcomes, and stakeholder input filed in an accurate and timely manner. Coordinates change control documentation and approval process. Makes proposals and in the development of corrective action plans and monitors implementation. Follows up on closure of corrective and preventive actions. Provides quality support for technology transfer and improvement of existing manufacturing processes. Conducts investigations, collects data, analyzes trends and prepares reports for assigned quality processes. Assesses current quality systems and recommends improvements in order to enhance quality and reduce cycle time. Prepares for and facilitates audits and inspections. Monitors trends, identifies issues, recommends and implements appropriate actions. Assists in the development, implementation and review of standard operating procedures.

Leadership and Team Management:
Provide leadership and direction to the quality engineering team. Coach and mentor team members, lead professional development discussions, drive employee engagement.

Advise multi-functional managers on high-level initiatives for Quality Engineering, employing industry best practices to ensure optimal results.

Integrates Johnson & Johnson's Credo and Leadership Imperatives into team goals and decision making.


Responsible for the operational aspects of their team (eg, workflow, performance, and compliance), as well as ensuring achievement of team goals within established timelines and budgets.


Quality Assurance:
Collaborate with cross-functional teams to establish and maintain quality assurance processes throughout the manufacturing lifecycle (NPI through end of life)

Own the manufacturing MRB Process through sustaining and improvement activities. Use data generated from MRB to drive improvements to the manufacturing and quality system process.


Audit technical support activity to production areas in evaluating process improvement opportunities and subsequent modifications, to produce timely and effective Quality Engineering solutions.

Examine results from management reviews, third party inspections and internal audits and approves proposed corrective actions.


Evaluating and implementing improved manufacturing engineering performance management systems and tracking tools, as well as facilitating resolution of complex technical, quality and operational problems.


Ensure adherence to Good Manufacturing Practices (GMP) and other relevant quality standards through document reviews, Gemba walks, and influencing other functions to embrace a quality culture and mindset.

Lead process validation efforts, ensuring that manufacturing processes are validated according to Abiomed's SOP's and industry best practices.

Implement statistical tools and methodologies for process optimization and control (IQ, OQ, PQ, PPQ, TMV, Gauge RR, Cpk, SPC).

Qualifications
Bachelor's degree in Engineering or a related field required; advanced degree preferred.

Minimum of 8 years of experience in quality engineering within the medical device or a similar highly regulated industry.

Strong understanding of FDA regulations (Medical Device), ISO standards.

Proven experience in leading and managing cross-functional teams.

Excellent communication, interpersonal, and problem-solving skills.

International travel 10%-25% required

Experience in SAP, ETQ and Minitab desired

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit
Primary Location

NA-US-4887-Woburn
Organization

ABIOMED Inc.(6942)
Job Function

Quality Assurance

Req ID:

W
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