Senior NPD Quality Engineer

Johnson & Johnson Innovative Medicine • Raynham, MA

1d • $92,000 - $148,350 • Onsite

About The Position

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 Manufacturing. This role is for our Mitek Sports Medicine organization supporting our soft tissue solution portfolio of products.

Requirements

• A minimum of a Bachelor's degree is required.
• 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.
• Experience handling tasks or small projects and demonstrating project leadership abilities.
• Strong communication skills and teamwork skills to support partnering cross functionally.
• Ability to effectively collaborate and communicate with internal and external partners and demonstrate strong interpersonal, organizational, and verbal/written communications skills.

Nice To Haves

• Degrees in Engineering or related technical/scientific field is preferred.
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Experience working in both an FDA and European regulatory environment is preferred.

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.
• 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.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior