Supplier Quality Engineer I

Johnson & Johnson•Raynham, MA

23h•Onsite

About The Position

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. 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.

Requirements

A minimum of a Bachelor's Degree or equivalent is required.
Generally Requires 0-2 years work experience.
Strong communication, teamwork, and problem solving skills are required.
Strong root cause analysis skills are required.

Nice To Haves

A Degree in Engineering or related discipline is preferred.
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.
Experience or knowledge with machining manufacturing processes, 3D printing, and injection molding is preferred.
Six Sigma, Lean, or ASQ Certification and trainings are preferred.

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.

Benefits

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.
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 period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year