Senior Mgr, Design Quality & Integration

Description

Johnson & Johnson is currently seeking a Senior Mgr., Design Quality & Integration to join our Abiomed Teamlocated at either Danvers, MA office or On-site at J&J MedTech location with travel to Danvers required. This is a duration-based role for 18 months.

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

Key Responsibilities:

Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.

Must have in-depth knowledge of and ability to apply quality system regulation, including QSR, ISO 13485, MDSAP and MDD/MDR.

Contribute to the development of Quality System performance measures, data collection, trending, and reporting. Assures that data obtained during all quality activities is complete, accurate and documented consistently.

Provide support during Corrective and Preventive Action (CAPA) activities and Nonconformance related activities.

Support Internal Audit program, e.g., participate/lead Internal audits, follow up on the finding with auditee through effective closure, present the data for trending, etc.

Ensure compliance of QMS through authoring and updating Standard Operating Procedures (SOP).

Lead actions to standardize and improve Component Qualification processes and procedures across multiple sites.

Provide leadership for External Manufacturing and Supplier Quality processes across multiple sites.

Lead actions related to production and process controls.

Provide leadership for any assigned integration workstreams and related implementation activities.

Support New Product Development projects to drive execution across the full design quality engineering team.
Qualifications

Education:

A minimum of a Bachelor's degree in an engineering or scientific field is required.

Required Skills & Experience:

A minimum of 8 years of work experience in a highly regulated industry

Excellent problem solving, decision-making skills, and interpersonal skills that facilitate clear communication

Strong analytical and technical writing skills

Project management skills including strong initiative and follow through in driving project responsibilities, overcoming obstacles, and balancing multiple priorities effectively through strong technical and/or project leadership experience

Knowledge and application of QSR/GMP/Google Cloud Platform/ISO regulations as related to medical device

Working knowledge and practical application of 21 CFR Part 820, ISO 13485, and ISO 14971

Proficient in English verbal and written communication

Preferred Skills & Experience:

Medical Device and/or Pharmaceutical industry

Quality engineering experience

Ability to summarize & effectively communicate complex ideas

Persuasive, ability to be a change agent capable of influencing without direct authority

Comfortable with collaborative and cross-functional tasks & decisions

Demonstrate a high level of integrity and implementation of Credo-based actions

Component qualification knowledge

Experience working with suppliers (direct and external manufacturing)

Design control or new product development

Experience conducting Process / Design Failure Mode Effects and Analysis

Experience supporting or conducting Process Verification / Validation activities

Experience with Blueprint reading/literacy including GD&T

Familiarity with inspection methods and techniques

Process Excellence/Lean experience

Ability to work in cross-functional teams that span global operations

Other:

Position is based at either the Abiomed HQ in Danvers, MA office or On-site at J&J MedTech location with travel to Danvers is required

This is a duration-based role for 18 months

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.

The base compensation for the role is between $118,000-$203,550. 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. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

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.

Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

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

For additional general information on Company benefits, please go to: -

This job posting is anticipated to close on 5/23/24. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.