Senior Director, Quality Engineering

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A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully.

J&J Family of Companies - Senior Director, Quality Engineering - Denver, Colorado

Senior Director, Quality Engineering - 2406198741W

Description

Medical Device Business Services Inc. is recruiting for a Senior Director, Quality Engineering to be located in West Chester, PA, Raynham, MA, Palm Beach Gardens, FL, Zuchwil, Switzerland, Leeds, England, Cork, Ireland or a Johnson and Johnson site in the United States.

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.

The Senior Director Quality Engineering will be accountable for the development, execution, and delivery of quality strategies for DPS TECA and Mitek Sports Medicine lifecycle management (LCM) and new product introduction (NPI) engineering activities.

Acts as the Quality Management Representative for Synthes West Chester, PA sites : Headquarters, Technology Center, and Wilson Drive Development Center.

Acts as Quality Management Representative for Depuy Mitek Raynham, MA.

Responsibilities :

• Will be a member of DPS TECA & Mitek Sports Platform Operating Committee and will provide the quality strategic vision for the organization.
• Will provide guidance and coaching to all levels within the Quality organization and Quality leadership for the business.
• Will partner with R&D, Supply Chain, Regulatory & Marketing to assure all LCM / NPI engineering and quality deliverables are met within quality, cost, and schedule targets.
• Will manage overall quality budget, ensuring effective allocation of resources and investments to achieve quality objectives.
• Will be accountable for quality metrics to identify systemic product and process issues assuring appropriate investigation, correction, and corrective and preventive action when needed.
• Will be responsible for the Synthes and Mitek Quality Management Review.
• Will support Quality related activities for product issue escalation, investigations (PIE / PIA) and QRB.
• Will partner with Supplier Quality and Manufacturing, to ensure Quality strategy is aligned with J&J Med Tech Quality strategies.
• Will host FDA / TUV / BSI and other Health Authority audits.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Qualifications

Education :

A minimum of a bachelor's degree in a technical field is required.

Experience and Skills :

Required :

• A minimum of 12 years quality assurance management experience in medical devices is required.
• Strong knowledge of design control requirements is required.
• Direct experience leading Notified Body / FDA audits is required. Strong knowledge of FDA and EU regulatory compliance for Medical Devices is required.
• Previous experience managing multiple projects is required.
• Experience of developing concise and audience-focused communications, both written and for presentations is required.

Preferred :

• Previous Biomaterials experience is preferred.
• Experience in pharmaceuticals or Biologics is preferred.

Knowledge, Skills and Abilities :

• Strong problem solver with a proven ability to identify multiple possible solutions when faced with quality issues / opportunities.
• Ability to effectively present complex information in a clear and concise manner is required.
• Strong relationship builder who can earn the trust of internal and external stakeholders.
• Ability to effectively negotiate and influence upper management, other departments and regulatory agencies is required.
• Highly motivated individual with excellent interpersonal communication skills.
• Ability to clearly communicate to a variety of audiences, both big picture ideas as well as technical details is required.
• Excellent communication and interpersonal skills are required.

Other :

25% travel is required.

The anticipated base pay range for this position is $187,000 to 322,000.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.

Employees and / or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs : medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

This position is eligible to participate in the Company’s long-term incentive program.

Employees are eligible for the following time off benefits :

• Vacation up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year
• Holiday pay, including Floating Holidays up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

This job posting is anticipated to close on 7 / 22 / 24. The Company may however extend this time-period, in which case the posting will remain available on https : / / www.

careers.jnj.com to accept additional applications.

Primary Location : NA-US-Pennsylvania-West Chester

Organization : Medical Device Business Services, Inc (6029)

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