Quality Assurance Manager, Medical Device & Combination Products

Description

The company's global quality team covers development, sustaining and post-market work for medical device and combination product portfolios sold in more than 50 markets worldwide.

You will be a key global quality partner, leading quality oversight for these portfolios and supporting the global quality blueprint.

Your work affects patients directly, whether you are involved in development, maintenance, compliance or analysis within research programs.

This is an individual contributor role with no direct reports.

Responsibilities

• Lead quality assurance oversight for several global programs at once, including next-generation delivery platforms, to support launch and long-term market supply of priority products.
• Ensure delivery systems are developed and sustained in line with ISO 13485, ISO 14971, EU MDR, 21 CFR Part 4 and FDA 21 CFR 820.
• Provide strategic and technical quality oversight of design controls and risk management on complex programs, guiding teams toward risk-based decisions that meet design control and quality system rules.
• Act as the quality partner for global cross-functional teams on design controls, post-approval changes, supplier and component changes, manufacturing transfers, periodic product reviews, post-market surveillance, remediations and obsolescence planning.
• Resolve complex, multi-region quality and compliance issues that matter to the business, giving recommendations that lead to practical, compliant decisions across international markets.
• Keep up with changing rules in regions such as the EU, Australia, Brazil, China and the US, and turn them into global policies, procedures and quality system practice.
• Review investigations for completeness, scientific justification, links between issues, risk alignment and whether a CAPA is needed.
• Help teams solve complex quality problems and reach compliant decisions in fast-moving, heavily regulated settings.
• Find ways to tighten processes, make practice more consistent and mature the quality system across development and sustaining work for these products.
• Make sure policies and procedures are read and applied the same way across teams.
• Apply technical knowledge to later lifecycle stages, including verification, validation, process validation, stability questions and managing marketed products.

Requirements

• Degree and experience, meeting one of these: a bachelor's degree with at least 4 years; a master's degree with at least 2 years; a PhD with 0+ years; an associate's degree with 8 years; or a high school diploma or equivalent with 10 years of relevant experience. The experience must be in quality assurance, a GMP manufacturing setting, a pharmaceutical setting or the medical device space.
• Hands-on support for quality work in medical devices, combination products, pharmaceuticals or another tightly regulated industry.
• Practical knowledge of quality and regulatory requirements for medical devices and/or combination products or pharmaceuticals, including design controls, risk management and quality system rules.
• Experience supporting development or sustaining work, including change control and ongoing product upkeep.
• Skill at working across functions and making sound, risk-based calls when situations are complex or unclear.
• Clear communication, influence and collaboration.
• Good analytical skill and comfort working with quality documents, systems and data.
• Bonus: experience in both medical device and pharmaceutical quality, especially with combination products.
• Bonus: deep design control and risk management work, from early development through launch and afterwards in market.
• Bonus: involvement in on-market changes, post-approval changes, supplier or component changes and manufacturing transfers.
• Bonus: post-market surveillance, complaint review, periodic product review and remediation work.
• Bonus: working knowledge of combination product rules, including 21 CFR Part 4, and wider medical device regulatory expectations.
• Bonus: experience working with suppliers, vendors or outside manufacturers in a regulated setting.
• Bonus: applying a risk-based approach to difficult quality calls in fast-moving, cross-functional work.
• Bonus: familiarity with verification, validation, process validation, usability, software or other technical development areas for medical devices.

Conditions

This is a hybrid role, with 2 to 3 days per week on premise.

Travel across manufacturing sites, vendors and suppliers may include this role.

Base salary ranges from $99,200.00 to $165,400.00 per year. This US range does not apply to Tampa, FL or any location outside the US.

Pay and benefit structures follow the location of hire.

The role is posted in several locations. Where local pay transparency rules apply, your talent adviser will share local pay details during the first interview.

Relocation support is available, and assistance may also depend on business needs and/or eligibility.

Applications close on November 13, 2026.

You must be authorized to work in the US for any employer.

US work visa sponsorship, such as TN, O-1 or H-1B, is not offered for this role now or in the future.

Licensed physicians who incur recruiting expenses that the company pays or reimburses will have their name, address and payment amount reported to the government under the US Sunshine Act.

Benefits

• Eligibility for the Global Performance Plan, with a bonus target of 12.5% of base salary.
• Eligibility for the share-based long-term incentive program.
• 401(k) plan with company matching contributions and an additional retirement savings contribution.
• Paid vacation, holiday and personal days.
• Paid caregiver, parental and medical leave.
• Medical, prescription drug, dental and vision coverage.
• Full benefit details are on the company's US candidate benefits site.