Design Quality Engineer II

Johnson & Johnson Innovative Medicine•Warsaw, IN

1d•$76,000 - $121,900

About The Position

Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics 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. DePuy Synthes (Johnson & Johnson MedTech) is recruiting for a CPD/LCM Design Quality Engineer II to be located in Warsaw, IN. The Design Quality Engineer II, applies basic Quality Engineering/Scientific Method techniques and principles to daily tasks and activities under general supervision. In addition, applies relevant regulations, standards, and industry best practices to assignments. The Quality Engineer participates in and performs tasks on projects and assignments with technical responsibility or strategic feedback. They receive intermittent, detailed instructions from technical Quality leaders at different levels, in addition to other partners. The Quality Engineer should excel in an environment that encourages teamwork, change, risk-based decision-making and flexibility. Also, they should be able to communicate effectively with Quality leaders and other departments such as R&D, Regulatory, Manufacturing, and Marketing.

Requirements

University/ Bachelor's degree or equivalent required
Minimum of two (2) years of relevant work experience required, preferably within a regulated environment (e.g. FDA regulated)
Basic knowledge of Quality Engineering/Scientific methods and techniques
Basic technical understanding of manufacturing equipment and processes
Basic understanding and application of measuring techniques (for example mechanical, optical, gauges, automation)
Experience leading tasks or small projects and demonstrating project leadership abilities
Ability to work both independently and partner with a multi-functional team
Fluent in English (written & verbal) is required

Nice To Haves

Advanced degree or focused degree within Engineering, Technical, or Scientific field preferred
Knowledge of the QSR, Design Controls, and ISO quality requirements
Quality Engineering/Design or Process Excellence/Lean experience
Experience conducting Process / Design Failure Mode Effects and Analysis
Problem solving techniques including root cause analysis and cause and effect analysis
Excellent negotiation, decision-making, and interpersonal skills that cultivate conflict resolution as it relates to technical situations
ASQ certification

Responsibilities

Works with Product Development, CxE, Manufacturing, Supplier Quality, Post Market, Regulatory, MTO, and Marketing on product and process improvement projects for implants and instruments.
Assists with the creation or update of assorted design control, process control, risk management, inspection, test, marketing, and regulatory documents.
Supports process verification/validation activities for suppliers.
Proven proficiency applying various tools and methods (e.g., Six Sigma, Lean) to identify and realize new product or process introductions as well as process improvements.
Proven proficiency applying a variety of risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode, and effects analysis).
Collaborates on the reliability assessments of product design.
Run root cause investigations using various problem solving methods and tools, and assesses effectiveness of corrective actions.
Support the development of test methods in equipment, process, and product qualifications/validations.
Ensures that process Quality control plans are aligned in accordance with product risk level and are consistently followed.
Implements and/or maintains, production and process controls using appropriate methods (process capability measures, statistical process controls, and process performance metrics).
Participates in technical reviews as appropriate.

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
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year