Hybrid Senior Quality Engineer

at OneTrust

• Job title: Senior Quality Engineer
• Job type: Full Time
• Experience level: Senior
• Salary: $92,000 - $148,350 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Cincinnati, United States

About the role

• Senior Quality Engineer at J&J MedTech focusing on quality engineering across product life cycles. Leading design implementation, ensuring compliance, and overseeing testing at various manufacturing sites.

Responsibilities

• Provides leadership in design and implementation of world-class quality engineering to support entire product life cycle with focus on quality engineering activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the product
• Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes; acts as technical liaison, as needed, between product development, manufacturing, external manufacturers, and suppliers
• Reviews and edits all engineering documentation related to assigned projects, such as technical reports, work instructions and method and process validation; provides review and approval for the release of new products and design changes ensuring quality requirements are met
• Applies intermediate Quality Engineering/Scientific Method techniques and principles to daily tasks and activities.
• Plans and conducts projects and assignments with technical responsibility or strategic input.
• Addresses and corrects product and process complaints through data analysis, continuous product improvement, and/or corrective and preventive actions.
• Communicates business related issues or opportunities to next management level
• Oversees audits of quality system categories to assess compliance to process excellence standards.
• Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management which outline findings.
• Performs and/or oversees complex hands-on and simulated testing for design verification and test method developments; inspects and oversees testing of prototypes, tools, and fixtures after fabrication to ensure that they meet specifications.

Requirements

• A bachelor’s degree in engineering from an accredited engineering or relevant science/technical school is required.
• A degree in Mechanical, Electrical, Biomedical or other equivalent technical degree is preferred.
• Non-STEM graduates with follow-on technical training or experience will also be considered.
• Appropriate relevant advanced degrees are preferred.
• Generally requires minimum of 4 years’ work experience.
• Experience in a regulated industry or veterans with leadership experience will be given preference.
• Experience with Risk Management (ISO 14971), Medical Device Quality Management System (ISO 13485), Gage repeatability and reproducibility theory and application, statistics, project management (supporting multiple projects simultaneously), and reliability is strongly preferred.
• Auditing skills such as - ISO, QSR (Quality Systems Regulations), MDSAP, and GMP standards are preferred.
• An ASQ certification (CQE, CQM, CRE or CQA) is an asset.
• Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset.

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