Design Quality Engineer II

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

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 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 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.

Key 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.

Qualifications

Education:

• University/ Bachelors degree or equivalent required

• Advanced degree or focused degree within Engineering Technical or Scientific field preferred

Experience and Skills:

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

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

Other:

• Fluent in English (written & verbal) is required

• This position may require up to 25% of domestic and/or international travel

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

Additional Description for Pay Transparency:

IC