Senior Quality Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

Job Function:

R&D Product Development

Job Sub Function:

Biomedical Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Cincinnati Ohio United States of America Danvers Massachusetts United States of America Irvine California United States of America Raritan New Jersey United States of America

Job Description:

J&J MedTech is recruiting for a Senior Quality Engineer located in Cincinnati OH.

The role of a Senior Quality Engineer at J&J MedTech is to apply the principles of engineering mathematics statistics organizational excellence and risk management to help the company achieve two major objectives in support of the J&J Credo:

• Meet and exceed the expectations of our customers

• Achieve and maintain compliance with regulatory expectations

The Senior Quality Engineer provides overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products and ensures compliance to good manufacturing practices international organization for standardization and any other applicable standards. Depending on job needs a Senior Quality Engineer may work in:

• New product development / new product introduction / new process introduction

• Supply chain (life cycle engineering manufacturing assembly or supplier quality)

• Quality systems and business processes

Key Job Responsibilities:

Under limited supervision and in accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position:

• Provides leadership in design and implementation of world-class quality engineering to support entire product life cycle with focus on quality engineering activities such as reliability risk management analytics/statistical techniques requirements management verification & validation and design control across the lifecycle of the product

• Provides complex product team support for quality system design and audit compliance assessment and for support of steady state manufacturing processes; acts as technical liaison as needed between product development manufacturing external manufacturers and suppliers

• Reviews and edits all engineering documentation related to assigned projects such as technical reports work instructions and method and process validation; provides review and approval for the release of new products and design changes ensuring quality requirements are met

• Applies intermediate Quality Engineering/Scientific Method techniques and principles to daily tasks and addition applies relevant regulations standards and industry best practices to assignments.

• Plans and conducts projects and assignments with technical responsibility or strategic input. Receives intermittent moderately detailed instructions from technical Quality leaders at various levels in addition to other stakeholders.

• Addresses and corrects product and process complaints through data analysis continuous product improvement and/or corrective and preventive actions

• Communicates business related issues or opportunities to next management level

• Oversees audits of quality system categories to assess compliance to process excellence standards

• Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify bracket correct and prevent defects presenting reports to management which outline findings

• Performs and/or oversees complex hands-on and simulated testing for design verification and test method developments; inspects and oversees testing of prototypes tools and fixtures after fabrication to ensure that they meet specifications

• Studies specifications engineering blueprints tool orders and shop data and confers with engineering and shop personnel to resolve design problems related to material characteristics dimensional tolerances service requirements manufacturing procedures and cost

• Ensures personal and Company compliance with all Federal State local and Company regulations policies and procedures

• Performs other duties assigned as needed

• May support technical training (i.e. statistics and quality methods) and teaching/mentoring of others

Key Skill and Knowledge Requirements:

• Candidate must have strong analytical problem-solving skills and be able to contribute to or lead root cause investigations using various problem solving techniques and tools and assess effectiveness of corrective actions

• Candidate must have sound statistical application in areas such as DOE sampling techniques regression reliability FMEA hypothesis testing etc.

• Experience with project management and the ability to work with multiple simultaneous priorities in a highly matrixed environment is required

• Demonstrated experience working within a team obtaining feedback negotiating and positively influencing is required

• Ability to understand new concepts quickly research and maintain ongoing learning of industry regulations is required

• Fundamental technical understanding of manufacturing equipment and processes is preferred

• Prior experience working with Risk Analysis and Risk Management is also preferred

• Advanced quality systems (AQS) experience preferred

• Knowledge of: Regulatory compliance GMPs MDD (Medical Devices Directive) 510K (Pre-market Notification) PMA (Pre-market Approval) and Government trade association industry & medical publications desired.

Qualifications:

• A bachelors degree in engineering from an accredited engineering or relevant science/technical school is required. A degree in Mechanical Electrical Biomedical or other equivalent technical degree is preferred.

• Non-STEM graduates with follow-on technical training or experience will also be considered. Appropriate relevant advanced degrees are preferred.

• Generally requires minimum of 4 years work experience. Experience in a regulated industry or veterans with leadership experience will be given preference.

• Experience with Risk Management (ISO 14971) Medical Device Quality Management System (ISO 13485) Gage repeatability and reproducibility theory and application statistics project management (supporting multiple projects simultaneously) and reliability is strongly preferred.

• Auditing skills such as - ISO QSR (Quality Systems Regulations) MDSAP and GMP standards are preferred.

• An ASQ certification (CQE CQM CRE or CQA) is an asset. Six Sigma (Green Belt Black Belt etc.) or Process Excellence certification is an asset.

This position will be located in Cincinnati OH and may have up to 10% of both domestic and international travel.

Johnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodationexternal applicants please contact us via .Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Problem Solving

Preferred Skills:

Analytical Reasoning Bioinformatics Biological Engineering Biological Sciences Biostatistics Coaching Data Savvy Detail-Oriented Feasibility Studies Inventory Management Preclinical Research Project Schedule Prototyping Research and Development Researching SAP Product Lifecycle Management Technologically Savvy

The anticipated base pay range for this position is :

$92000.00 - $148350.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).



This position is eligible to participate in the Companys long-term incentive program.



Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:

Vacation 120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year

Holiday pay including Floating Holidays 13 days per calendar year

Work Personal and Family Time - up to 40 hours per calendar year

Parental Leave 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave 80 hours in a 52-week rolling period10 days

Volunteer Leave 32 hours per calendar year

Military Spouse Time-Off 80 hours per calendar year

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

Senior IC