General Electric Company

Manager, Quality, PPC - Surgery

General Electric Company • $100K — $130K *
Salt Lake City, UT 84118In-Person
Hospitals & Medical Centers
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree or high school diploma with extensive experience in regulated medical device or pharmaceutical industry.
  • 6 years minimum relevant experience, or 10+ years with a high school diploma.
  • 2 years minimum of supervisory or project leadership experience.
  • Strong communication skills in English, both written and oral.
  • Proficient in word processing, spreadsheets, and presentation software.
  • Understanding of Medical Device QMS and regulatory requirements (FDA CFR 21 820, ISO 13485).
  • Hands-on experience with FDA, QSR, ISO, MDD, and other quality systems.

Responsibilities

  • Ensure quality and regulatory compliance while enhancing process effectiveness.
  • Represent GE HealthCare to external agencies and lead the quality culture evolution.
  • Oversee Site Quality Planning and improvements across all aspects.
  • Lead a team and provide thought leadership in quality and compliance.
  • Manage critical quality-related decisions including production holds and project milestones.
  • Facilitate communication and training on quality standards for site employees.
  • Guarantee site audit readiness and conduct quality system inspections.
  • Support Corrective Action/Preventive Action (CAPA) initiatives and report on quality system effectiveness.

Benefits

  • Relocation assistance provided.
Full Job Description
Job Description Summary
This position is responsible for ensuring quality and regulatory compliance of a large facility, while driving process efficiency. The position provides key leadership to support the Supply Chain Activities at the Site, including Production and Process Control, Lean, and Supplier Quality. This position represents GEHC to external agencies and champions the evolution of the quality culture for the site which includes driving site quality objectives, metrics, reporting and operating mechanisms.

Job Description
Roles and Responsibilities
  • Ensures quality and regulatory compliance while driving process effectiveness and efficiency.
  • Represents GE HealthCare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.
  • Maintains and improves all aspects of Site Quality Planning
  • People leader with direct reports. Deep expertise within quality to drive compliance and continuous improvement in Quality processes. Provides professional or thought leadership. Influences policy and ensures delivery within Quality, linking with other functions of the organization.
  • Has authority to stop production, issue product holds (stop orders), make decisions about budgets and people accountability, release products and sign off on project milestones (i.e. New Product Introduction) Maintains and improves all aspects of Site Quality Planning
  • Oversees all Quality-related communications and training requirements for all site employees Maintains positive agency relationships-liaisons with regulatory agencies upon site inspections and participates in external technical forums
  • Ensures site audit readiness and hosting Quality System audits and inspections
  • Supports the Corrective Action / Preventive Action activities and Reports on Quality System effectiveness and requirements to management team as required.
  • Drives the definition of site quality objectives, metrics, reporting and operating mechanisms


Required Qualifications
  • Bachelor's degree and minimum of 6 years working in a regulated medical device or pharmaceutical industry (or a high school diploma with 10+ years working in a regulated medical device or pharmaceutical industry)
  • Minimum of 2 years supervisory/management or project leadership experience.
  • Ability to communicate effectively in English (both written and oral).
  • Demonstrated experience using word processing, spreadsheet, and presentation software.
  • Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
  • Hands-on experience with FDA, QSR, ISO, MDD and/or other international quality systems requirements


Desired Characteristics
  • Minimum of 5 years supervisory/management experience is preferred
  • Proven process development and project management skills
  • Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
  • Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions
  • Excellent communication skills (written and oral)
  • Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
  • Demonstrated working knowledge to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc
  • Experience leading, implementing, and accelerating change
  • Strong influencing, relationship building, mentoring & networking skills
  • Demonstrated collaboration & conflict resolution skills
  • Proven track record in performing & leading internal and external audits
  • Exceptional analytical, problem solving & root-cause analysis


We will not sponsor individuals for employment visas, now or in the future, for this job opening.

Relocation Assistance Provided: Yes

About General Electric Company

GE Healthcare provides medical technology, intelligent devices, and care solutions. They offer medical imaging, information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies. GE Healthcare's mission is to improve patient care and outcomes by providing innovative healthcare solutions. Their technologies are used in hospitals, clinics, research institutions, and pharmaceutical companies worldwide to diagnose and treat various medical conditions.

General Electric Company Careers

Join the dynamic team at General Electric Company, a global leader in innovation and technology. As one of the most respected companies worldwide, we offer unparalleled job opportunities that propel your career to new heights. Work You’ll Do At General Electric Company, you’ll be part of a diverse team committed to transforming industries and improving lives through leadership in sectors such as aviation, power, renewable energy, and healthcare. Our culture thrives on innovation and leadership, fostering an environment where you can grow professionally and personally. Lead in a Unique Market Position General Electric Company stands at the forefront of digital and industrial transformation. Here, you’ll leverage your skills to solve complex challenges, drive growth, and lead projects that have a global impact. Our commitment to professional development and diversity training ensures that every team member is equipped to lead and innovate. Collaborate with Industry Experts Work alongside a global network of professionals, each bringing a wealth of knowledge and experience to our collaborative projects. General Electric Company’s culture of inclusivity and teamwork makes it a prime environment for networking and personal development. Innovative Work Join us to work on groundbreaking projects that redefine what’s possible. Our teams at General Electric Company are constantly pushing the boundaries of technology and innovation to create solutions that not only meet but exceed the needs of our customers and communities around the world. Be Part of a Great Team At General Electric Company, we understand that our employees are our greatest asset. That’s why we offer competitive benefits, extensive career advancement opportunities, and a supportive environment that values work-life balance. Our commitment to employee growth is reflected in our robust training programs and our focus on internal mobility. Future-Proof Your Career With a career at General Electric Company, your growth is limitless. Through our various training programs, internships, and leadership development initiatives, you can enhance your skills and advance your career in a direction that aligns with your professional and personal aspirations. Explore Job Opportunities and Internships Whether you’re starting your career or looking to make a significant impact in your field, General Electric Company offers a range of positions and employment opportunities that cater to your talents and ambitions. From internships that provide real-world experience to leadership roles that challenge your strategic thinking, there’s a place for you here. Stay Connected Join Our Team Search open positions that match your skills and interests. We are always on the lookout for passionate, curious, and solution-driven team players. Explore the possibilities that await you at General Electric Company. Keep Up to Date Stay informed with career tips, insider perspectives, and industry-leading insights—all from the people who work here. At General Electric Company, we’re more than a company—we’re a community. Job Alert Emails Customize your subscription to receive job alerts, the latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities available at General Electric Company and become part of a team that’s reshaping the future of technology and industry. Join General Electric Company today and be a part of our journey to build a better world through essential technology and innovative solutions. Your career at General Electric Company awaits—explore, innovate, and lead with us.
Learn more about General Electric Company
Size
168,000 employees
Market Cap
$90.4 billion
Industry
Business Services
Net Income
$5.7 billion
Founded
1892
5 Year Trend
-9.1%
Revenue
$79.6 billion
NASDAQ
GE
* Ladders Estimates

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