Position Overview

The Principal Supplier Quality Engineer performs work with minimal guidance to provide and implement solutions to broad problems and accomplishes complex assignments. The scope of responsibilities includes supporting manufacturing operations, managing suppliers, and working with cross-functional groups to address quality issues. The Principal Supplier Quality Engineer makes decisions related to scope of work, risk management, process improvements, material disposition, and the implementation of revised product specifications.

Essential Job Functions

Supplier Management

• Partner with Procurement, R& D, Operations, Quality, and Suppliers in the timely investigation, resolution, and prevention of supplier quality issues which could disrupt business operations

• Define, monitor, and analyze supplier performance metrics; identify improvement opportunities and implement improvement projects; identify and address supplier risks and/or opportunities and communicate to the next management level

• Create Supplier Audit Schedules based on QMS procedures, component risk levels, supplier performance metrics, and input from Management Reviews

• Plan, schedule, execute, report, and follow-up on supplier audits

• Initiate, issue, review, and approve Supplier Corrective Action Reports (SCARs)

• Drive corrective actions for supplier processes by driving suppliers to true root cause analysis and corrective and preventive actions

• Own, manage, and drive to completion Supplier Change Assessments (SCAs)

• Act as the technical lead supporting regulatory submissions

• Lead component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups

• Compile, analyze, and summarize supplier performance data for Supplier Scorecards

• Assist in preparing Supplier Quality Agreements

• Map Supplier Management processes, perform gap analysis, and define and implement improvement projects

Manufacturing Support

• Review, investigate, disposition, and drive to completion Non-conforming Reports (NCRs) and Corrective and Preventive Actions (CAPAs)

• Initiate, review, and approve Document Change Orders (DCOs)

• Provide technical support and guidance to the Quality Control group

• Provide technical leadership and mentoring to lower-level engineers

• Collaborate with Manufacturing Engineering on process improvement projects

• Investigate customer complaints and document investigation findings

• Participate in internal and third-party audits (FDA, Notified Body)

• Participate in decision-making at Material Review Board (MRB) meetings

• Define, plan, execute, and document Test Method Validations (TMVs)

• Define, plan, execute, and document Gage R& R Studies

• Map processes, perform gap analysis, and define and implement improvement projects (eg: internal audit program; dock-to-stock)

Manufacturing Line Transfers

• Lead cross-functional teams to define requirements and generate documentation for the transfer of manufacturing lines to Contract Manufacturers (CMs)

• Plan and provide on-site and off-site training to CMs on product inspection and testing

• Act as the primary point of contact with CMs, and provide remote and off-site support on matters related to Quality

• Review, approve, and help draft CM validation protocols and reports and risk documentation

• Monitor product quality and production rates at CMs and drive the resolution of production line issues

• Other duties as assigned

• BS degree in a related engineering discipline and 10+ years of related experience, or

• MS degree in a related engineering discipline and 8+ years of related experience

• Experience in the medical device industry is required

• Strong understanding of cGMP, FDA 820 QSR, ISO 13485, or other Quality Systems

• Strong technical writing skills

• Effective communication skills across all levels of the organization

• Must be proactive, self-motivated, and able to work independently with minimal guidance

• Ability to work independently in a fast-paced environment while managing multiple priorities

• Working experience in statistics (hypothesis testing, capability analysis, DOE, MSA, Gage R& R), Six Sigma, Lean

• Certifications (CQE, Lead Auditor, Six Sigma, Project Management) would be a plus

• Ability to travel up to 20% of the time

Pay Transparency:

• The anticipated salary range for this position is $100, 000 - $172, 500

• 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

• Additional information can be found through the link below. https: //www.careers.jnj.com/employee-benefits

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. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.