Senior NPD Quality Engineer

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:

The Senior New Product Development (NPD) Quality Engineer provides Quality Engineering leadership on new product development projects in the areas of Design Controls and Design Transfer to Manufacturing including but not limited to: Risk Management Design Verification and Validation Strategies and Design Transfer to role is for our Mitek Sports Medicine organization supporting our soft tissue solution portfolio of products.

DUTIES & RESPONSIBILITIES

• Independently provide directions and oversight of the new product development quality activities across assigned projects.
• Apply various tools and methods (for example Six Sigma Lean) to identify and realize new product or process introductions as well as process improvements.
• Apply various risk management and risk mitigation tools and practices for example mistake proofing critical control points failure mode and effects analysis.
• Supports the reliability assessments of product design.
• Lead root cause investigations using various problem-solving techniques and tools and assess effectiveness of corrective actions.
• Conducts and supports the development of test methods in equipment process and product qualifications/validations.
• Ensures that process Quality control plans are in accordance with product risk level and are consistently followed.
• Implements and/or maintains production and process controls using appropriate techniques (for example process capability measures statistical process controls and process performance metrics).
• Participate in technical reviews as appropriate.

Additional Duties:

• Responsible for communicating business-related issues or opportunities to next management level

• Responsible for following all Company guidelines related to Health Safety and Environmental practices as applicable.

• 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

EXPERIENCE AND EDUCATION

• A minimum of a Bachelors degree is required. Degrees in Engineering or related technical/scientific field is preferred.
• A minimum of 4 years of regulated industry experience in quality new product development or manufacturing engineering capacity is required.
• Strong knowledge of Quality Engineering/Scientific methods and techniques.
• Strong knowledge of GD&T and inspection methodologies.

• Experience with a proven track record of implementing appropriate risk mitigation.
• Technical training and experience using Statistics Lean and Six Sigma Methodologies is preferred including Measurement System Analysis SPC DOEs Reliability etc.

• Experience handling tasks or small projects and demonstrating project leadership abilities.
• Strong communication skills and teamwork skills to support partnering cross functionally.

REQUIRED KNOWLEDGE SKILLS ABILITIES CERTIFICATIONS/LICENSES and AFFILIATIONS

• Ability to effectively collaborate and communicate with internal and external partners and demonstrate strong interpersonal organizational and verbal/written communications skills.

• Experience working in both an FDA and European regulatory environment is preferred.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

Additional Description for Pay Transparency:

Senior IC