Staff Supplier Quality Engineer

Johnson & Johnson Innovative Medicine

20h•$94,000 - $151,800

About The Position

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. The Staff Supplier Quality Engineer provides overall quality assurance leadership in the management of select contract manufacturing sites and raw material suppliers engaged in the production of Johnson and Johnson products. The Staff Supplier Quality Engineer maintains the qualification of suppliers and their processes as well as lead activities associated with resolving complex technical issues that may require the development of new or improved techniques or procedures. The position is the technical specialist able to make independent decisions on technical problems and methods, provide technical leadership and project management to qualify and improve supplier processes for the manufacture of medical devices.

Requirements

Bachelor's Degree is required; Master’s Degree is preferred
Generally requires 4 – 6 years of work experience in a GMP and/or ISO regulated industry
Experience in the medical device / pharmaceutical industry is preferred
Engineering or science field of study is preferred
Excellent communication, teamwork, and problem-solving skills are required
Expertise in all aspects of quality event investigations such as root cause analysis followed by comprehensive corrective action suggestions
Experience with machining, injection molding, metal processing such as passivation, anodizing and heat treating, and/or electronics assembly are preferred
FDA CFR and ISO regulations knowledge is required, with FDA CFR Part 820 and ISO 13485 knowledge preferred.
Auditing background is a plus
Six Sigma, Lean, American Society for Quality (ASQ) certification and professional licenses are preferred
Strong statistical analysis skills are preferred
Fluency in English is required
Ability to work in stressful/fast-paced environment
Ability to work and interact with co-workers to accomplish company goals in a team environment
Management Skills
Analytical/Problem Solving Skills
Ability to communicate verbally and in writing
Ability to learn

Nice To Haves

Coaching
Communication
Compliance Management
Controls Compliance
Cross-Functional Collaboration
Data Compilation
Econometric Models
ISO 9001
Issue Escalation
Performance Measurement
Problem Solving
Quality Control (QC)
Quality Standards
Standard Operating Procedure (SOP)
Technologically Savvy
Vendor Selection

Responsibilities

Support Quality Systems including change control, supplier non-conformances, ASL management, Quality Agreements and department procedures and system, as assigned.
Perform and Support supplier/ EM quality evaluations and/or audits, development of quality agreements, and other quality related activities impacting supplier.
Lead activities associated with resolving supplier quality issues. This includes working with suppliers and internal partners to perform root cause analysis/failure investigations, identifying and implementing corrective actions, and monitoring for effectiveness.
Lead activities associated with supplier risk management. This includes working with suppliers to identify areas of high risk within their processes; establishing, monitoring and implementing supplier risk mitigation plans; participating in supplier risk management projects; and ensuring management awareness of risks, gaining support for mitigation efforts and tracking progress.
Lead activities associated with supplier process improvement. This includes working with suppliers to identify sources of variation within their processes; implementing process controls to improve process capability; and driving implementation of best practices.
Provide Quality Engineering support to suppliers including assessments, inspection technique support, verification/validation activities, CAPA and change management.
FDA CFR Part 820 and ISO 13485 regulations/standards focus.
Champions compliance to validation regulations & standards (e.g. QSRs, ISO, EN and MDD/MDR) including providing support during internal and external audits.
Utilizes multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).
Develop and report on supplier performance metrics.
Participate in local site supplier quality meetings to ensure communication and alignment of quality initiatives.
Responsible for communicating business related issues or opportunities to next management level.
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Performs other duties assigned as needed.

Benefits

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:
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: - https://www.careers.jnj.com/employee-benefits