Manager, Quality – Polyphonic

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:

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 were 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 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.

Key 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
  

Required Qualifications:

• A minimum of a Bachelors 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 FDAs 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%
  

Preferred Qualifications:

• 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

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via .Internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

#LI-Remote

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

Additional Description for Pay Transparency:

Manager