Manager, Quality – Polyphonic

Johnson & Johnson

Manager, Quality overseeing product quality and reliability for medical devices and digital solutions. Collaborating with multi-functional teams to ensure safe, effective product development.

Posted 5/8/2026full-timeCincinnati • 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 the next management level.
Responsible for ensuring personal and team compliance with all Federal, State, local and Company regulations, policies, and procedures.
Adherence to 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).
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%.

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

software developmentquality assurancesoftware testingdesign controlssoftware verificationvalidation protocolsrisk managementdocumentation practicestechnical design reviewsnew product development

Soft Skills

leadershipcommunicationcollaborationproblem-solvingteamworkpresentation skillsorganizational skillsadaptabilityattention to detailanalytical skills

Certifications

Bachelor's DegreeEngineering DegreeComputer Science DegreeSTEM DegreeAdvanced Degree