Manager, Quality – Polyphonic

Johnson & Johnson

Manager, Quality – Polyphonic position ensuring the product quality of medical devices at Johnson & Johnson. Supports cross-functional teams in quality assurance and compliance throughout the development lifecycle.

Posted 5/8/2026full-timeSanta Clara • California, Ohio • 🇺🇸 United StatesMid-LevelSenior💰 $118,000 - $203,550 per yearWebsite

Tech Stack

Tools & technologies

Cyber Security

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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)
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
Strong verbal and written communication skills; ability to present issues, plans and objectives

Benefits

Comp & perks

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

software developmentsoftware testingdesign controlssoftware verificationsoftware validationrisk managementdocumentation practicesquality management systemISO 13485IEC 62304

Soft Skills

leadershipcollaborationcommunicationteamworkproblem-solvinganalytical skillsattention to detailadaptabilityorganizational skillspresentation skills

Certifications

Bachelor’s DegreeMaster’s DegreeISO 14971 certificationIEC 62304 certificationFDA Software Validation certificationcybersecurity certificationquality management certificationrisk management certificationmedical device certificationproject management certification