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Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Raynham, Massachusetts, United States of America

Job Description:

OVERALL RESPONSIBILITIES:

DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.

The Supplier Quality Engineer I for Joint Reconstruction provides overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of DePuy Synthes Joint Reconstruction products.

POSITION DUTIES & RESPONSIBILITIES:

• Supports established contract manufacturing sites via audit support, driving compliance and quality improvement initiatives.

• Assists in the resolution of process and product nonconformance events.

• Collects and escalates product or process complaints.

• Calculates contract manufacturer performance metrics and assists in conducting management reviews.

• Aids the external manufacturer with change management activities.

• Prepares audits of all quality system categories to assess compliance to process excellence standards.

• Implements basic measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, demonstrating continuous improvement to management.

• Assists in technical issues for manufacturing processes that are to be transferred to satellite facilities.

• This individual will provide Quality Engineering support to suppliers including audits/assessments, inspection technique support, verification/validation activities, CAPA and change management.  

• FDA CFR Part 820 and ISO 13485 regulations/standards will be the focus.

• Additional duties as assigned.

• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.

• Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.

PROFESSIONAL & EDUCATIONAL EXPERIENCE REQUIREMENTS:

• A minimum of a Bachelor's Degree or equivalent is required.

• A Degree in Engineering or related discipline is preferred. 

• Generally Requires 0-2 years work experience.

• Experience in a GMP and/or ISO regulated industry is preferred.

• Experience in the medical device and/or pharmaceutical industry is preferred. 

• FDA and ISO regulations knowledge is preferred.

• Auditing background is preferred.

• Strong communication, teamwork, and problem solving skills are required. 

• Strong root cause analysis skills are required. 

• Experience or knowledge with machining manufacturing processes, 3D printing, and injection molding is preferred.

• Six Sigma, Lean, or ASQ Certification and trainings are preferred. 

DISCLAIMER:

This job description does not constitute an employment agreement between the employee and DePuy Synthes. The duties above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position. Duties of the job are subject to change as the needs of DePuy Synthes and the requirements of the job change.

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 accommodation,  external applicants please contact us via https://www.jnj.com/contact-us/careers.  Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

 

 

Preferred Skills:

Customer Centricity, Data Savvy, Document Management, Execution Focus, Good Automated Manufacturing Practice (GAMP), Issue Escalation, Lean Supply Chain Management, Process Control, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy

 

 

The anticipated base pay range for this position is :

$54,000.00 - $87,400.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are 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.



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

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-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