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Director Quality Engineer Fda Jobs in Florida (NOW HIRING)

Germfree Laboratories Inc

Quality Engineer

Ormond Beach, FL · On-site

$63K - $81K/yr

Reporting directly to the Director of Quality & Lean, this individual-contributor role applies ... Its products are engineered to support a range of customer and industry standards (cGMP / FDA 21 ...

Treace

Quality Engineer

Ponte Vedra, FL · On-site

$65K - $84K/yr

The Quality Engineer (QE) will be responsible for management and execution of assigned quality ... The QE shall have prior experience working within an FDA compliant Title 21 section 820 environment ...

Treace

Quality Engineer

Ponte Vedra, FL

$65K - $84K/yr

The Quality Engineer (QE) will be responsible for management and execution of assigned quality ... The QE shall have prior experience working within an FDA compliant Title 21 section 820 environment ...

Treace

Quality Engineer

Ponte Vedra, FL · On-site

$65K - $84K/yr

The Quality Engineer (QE) will be responsible for management and execution of assigned quality ... The QE shall have prior experience working within an FDA compliant Title 21 section 820 environment ...

Hearst

Director, Quality Assurance

Tampa, FL · Hybrid

The Director will partner closely with Engineering, Product, Architecture, Data/AI, Security, and DevOps to ensure predictable, high-quality releases that meet customer, regulatory, and ethical ...

Advita Ortho

Manager, Quality Engineering

Gainesville, FL · On-site

$90 - $120/hr

Director, Quality Management Systems Description Provide quality engineering leadership by ... FDA/ISO/EC/CMDR) * Collaborate with the E&D and Manufacturing project teams to ensure support from ...

atrion

Quality Engineer

Davie, FL · On-site

$66K - $85K/yr

Manages engineering projects. Supports the internal and external audit program. Uses statistical ... Participate in audits with FDA, ISO, MDD, and other regulatory agencies. * Lead major quality ...

Workila

Sr. Quality Engineer

Fort Lauderdale, FL

$84K - $114K/yr

Understanding of measurements methods DESCRIPTION OF DUTIES The Sr. Quality Engineer will ensure high level of compliance to FDA QSR/cGMPs and ISO 13485 in all assigned areas. Responsibilities ...

Danaher

Senior Quality Engineer

Pensacola, FL · On-site

$83K - $113K/yr

The Senior Quality Engineer is responsible for ensuring the quality of membrane products and ... Strong knowledge of ISO 13485, FDA QSR, ISO 9001, and risk management tools. Cytiva, a Danaher ...

Danaher

Senior Quality Engineer

Pensacola, FL

$83K - $113K/yr

The Senior Quality Engineer is responsible for ensuring the quality of membrane products and ... Strong knowledge of ISO 13485, FDA QSR, ISO 9001, and risk management tools. Cytiva, a Danaher ...

Dayton Granger, Inc.

Quality Engineer

Fort Lauderdale, FL · On-site

$68K - $88K/yr

Quality Engineer Company: DAYTON-GRANGER, INC (DG) Industry: Aviation and Aerospace Component ... YouTube - DAYTON-GRANGER, INC (DG) Direct Hire, Competitive Pay, Great Benefits, Work-Life Balance ...

Dayton Granger

Quality Engineer

Fort Lauderdale, FL · On-site

$68K - $88K/yr

Quality Engineer Company: DAYTON-GRANGER, INC (DG) Industry: Aviation and Aerospace Component ... YouTube - DAYTON-GRANGER, INC (DG) Direct Hire, Competitive Pay, Great Benefits, Work-Life Balance ...

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All JobsQuality Engineer Fda JobsDirector Quality Engineer Fda JobsDirector Quality Engineer Fda Jobs in Florida

Director Quality Engineer Fda information

What is the difference between Director Quality Engineer Fda vs Quality Engineer Fda?

AspectDirector Quality Engineer FdaQuality Engineer Fda
CredentialsTypically requires a Bachelor's degree in Engineering or Life Sciences, with certifications like ASQ CQE or ISO auditorRequires similar degrees and certifications, often entry to mid-level
Work EnvironmentLeads quality teams, oversees compliance, and strategic planning in manufacturing or biotech settingsPerforms hands-on quality testing, inspections, and process improvements
Industry UsageCommonly used in regulated industries like pharmaceuticals, biotech, and medical devicesUsed across manufacturing, biotech, and pharmaceutical companies for quality assurance

The main difference is that the Director Quality Engineer Fda holds a leadership role with strategic responsibilities, overseeing quality systems and compliance, while the Quality Engineer Fda focuses on operational quality tasks and testing. Both roles require similar credentials but differ in scope and seniority.

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The most popular types of Quality Engineer Fda jobs in Florida are:

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Director Quality Engineer Fda jobs near you

Principal Quality Engineer- Georgia

FloodGate Medical

Tampa, FL • On-site

Full-time

Medical, Life, Retirement, PTO

Posted 7 days ago

Job description

About Zywie
Founded in 2014, Zywie is a founder-led, privately held remote cardiac monitoring company on a mission to transform cardiovascular care. Our flagship product, the ZywieNano™ MCT Patch - the smallest cardiac monitoring patch on the market - delivers up to 30 days of continuous ECG monitoring paired with ZywieAI™, our proprietary AI-driven arrhythmia detection platform.
We have monitored over 500,000 patients, analyzed more than 1 trillion heartbeats, and generated 4.5 million unique clinical notifications. We are profitable, self-funded, and scaling fast - growing our commercial team from 3 to nearly 25 reps in five years. We are now entering the most exciting chapter of our growth: developing and bringing our own proprietary hardware to market. That's where you come in.
The Opportunity
As we transition from a software and services company to a full medical device manufacturer, we're building our Quality organization from the ground up - and we need a Principal Quality Engineer to lead that build. Our first proprietary hardware device is already in active FDA 510(k) submission, with three more devices behind it in our R&D pipeline. This is a foundational, highly visible role: you'll design, implement, and scale our Quality Management System while directly supporting the development and commercialization of our hardware portfolio, reporting to our Sr. Director, Quality & Regulatory Affairs.
What You'll Do
  • Design, implement, and maintain an ISO 13485 and FDA 21 CFR Part 820/QMSR compliant Quality Management System
  • Lead Design Control activities across the product lifecycle, including Design Inputs, Outputs, Verification, Validation, and Design Reviews
  • Lead ISO 14971 Risk Management processes - hazard analysis, FMEA, benefit-risk analysis, and risk management reporting
  • Support software development teams to ensure compliance with IEC 62304, and review software lifecycle and verification documentation
  • Build and manage our supplier quality program, including audits and qualification for our contract manufacturer
  • Lead CAPA, nonconformance, change control, and complaint handling processes
  • Support process validation, manufacturing readiness, and Design Transfer activities
  • Lead implementation and validation of our electronic Quality Management System (eQMS)
  • Prepare the organization for FDA inspections and ISO 13485 certification, including all supporting documentation
  • Partner cross-functionally with Engineering, Clinical, Operations, Regulatory Affairs, and Manufacturing
  • Mentor future Quality Engineers as our organization grows

What You'll Bring
  • Bachelor's degree in Engineering or a related technical discipline; Master's preferred
  • 5+ years of Quality Engineering experience in the medical device industry
  • Demonstrated experience building or significantly enhancing a Quality Management System - not just operating within one
  • Deep knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and IEC 62304
  • Experience supporting Class II and/or Class III medical devices
  • Experience supporting FDA inspections and ISO certification audits
  • Strong Design Controls and Risk Management expertise
  • Experience implementing electronic Quality Management Systems
  • Excellent communication and leadership skills
  • Preferred: experience in startup or high-growth medical device companies, and experience supporting software-enabled devices (SaMD/SiMD), including AI/ML-enabled devices
  • Preferred: ASQ Certified Quality Engineer (CQE), CQA, or equivalent certification

Compensation & Benefits
  • Competitive base salary plus performance bonus, commensurate with experience
  • Full travel reimbursement - flight, hotel, transportation, and daily meal stipend for Atlanta office visits
  • Health Insurance
  • PTO and Holidays
  • 401(k) with company match
  • Life Insurance & AD&D Insurance
  • Direct access to senior leadership and the opportunity to build something that matters
  • A lean, entrepreneurial culture that rewards results and moves fast when the right person is identified

Zywie is an Equal Opportunity Employer. Zywie does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

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