Manager, Quality – Polyphonic
About The Position
We are searching for the best talent for Manager, Quality – Polyphonic to join our Quality organization located in Santa Clara, California or Cincinnati, OH. Remote work options may be considered on a case-by-case basis and if approved by the Company. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech The Manager, Quality – Polyphonic is responsible for supporting product quality and reliability ensuring the implementation of ground breaking technology for medical devices and digital solutions is safe, effective, and follows applicable regulations, standards, and industry practices. Working closely with multi-functional teams, this individual will act as a domain authority for product quality throughout the development lifecycle. The individual reviews and assesses development activities (e.g., user needs, development / quality plans, requirements, architecture and design, verification and validation) to ensure that they align with applicable procedures, standards and regulatory requirements. Additional responsibilities may include but are not limited to supporting other areas of the Quality Management System such as CAPA, Complaints, post market surveillance and both Internal & External Audits.
Requirements
- A minimum of a Bachelor’s Degree is required.
- Degrees in Engineering, Computer Science or STEM (Science, Technology, Engineering, and Math) related field are preferred.
- Advanced degrees are a plus.
- Minimum 6 years' experience with quality assurance with a focus on software testing, design controls, software development, and or software verification & validation
- New product development experience
- Experience in medical device industry or other highly regulated field (Aerospace, Aviation, Automotive, Defense)
- Strong verbal and written communication skills; ability to present issues, plans and objectives
- Knowledge and proven application of standards such as IEC62304, FDA's General Principles of Software Validation, ISO 14971, and IEC60601 series
- Knowledge and proven application of global cybersecurity and privacy standards
- Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms
- Previous work experience engaging in a team-based environment
- Ability to travel up to 25%
Nice To Haves
- ASQ Certified Quality Engineer, ASQ Certified Reliability Engineer, and a Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean)
- Experience in launching and maintaining regulated Software as a Medical Device (SaMD)
- Experience with Artificial Intelligence / Machine Learning (AI/ML) based technologies and solutions.
- Experience in the application of Cybersecurity frameworks and Global Privacy Regulations
- Experience working in a Quality Systems and/or Regulatory Compliance-focused role
- Proficiency in the application of Agile Development processes
- Software DevOps tools
Responsibilities
- Review all project/program software development artifacts (e.g., plans, requirements, specifications, test protocols, test cases, test results, traceability, risk management documents, reports).
- May be required to manage technical writers and/or contractors, where applicable
- Provides direction and leadership for verification & validation of product software, software tools and components.
- Guide in establishing good software requirements, specifications, detailed design, verification & validation protocols and planning documentation.
- Collaborate with project/program teams to ensure software deliverables and tasks align with company procedures, global standards (ISO 13485, ISO14971, IEC62304), regulations (e.g., 21 CFR Part 820, 21 CFR Part 11, European Union Medical Device Regulation (MDR)), and applicable guidance.
- Participate in technical design reviews and project phase reviews.
- Apply knowledge of risk management to ensure a risk-based approach for design and development
- Identifies and implements any changes vital to ensure and maintain the continued suitability and effectiveness of the quality management system using quality policy, quality objectives, audit results, analysis of data, etc.
- Support internal and external audits by regulatory agencies, as required.
- Responsible for communicating business related issues or opportunities to next management level.
- Responsible for ensuring personal and team compliance with all Federal, State, local and Company regulations, policies, and procedures.
- Adherence Good documentation practices including change control.
- Other duties as assigned
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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
