General Electric Company

QA Manager

General Electric Company$90K — $120K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree from an accredited university or college
  • 7+ years in Quality Assurance within regulated industries, preferably Medical Devices or Pharmaceuticals
  • Understanding of Medical Device Quality Management Systems and regulations, including FDA CFR 21 820 and ISO 13485
  • Proven team leadership and management skills
  • Ability to effectively collaborate and resolve conflicts

Responsibilities

  • Ensure compliance of QMS processes such as Document Control and Complaint Management
  • Write and update quality documents, policies, and procedures
  • Investigate nonconformities and determine root causes
  • Develop product knowledge to influence product quality
  • Support audits with complete and accurate records
  • Track and monitor QMS processes with stakeholders
  • Implement process improvements for compliance and efficiency

Benefits

  • N/A
Full Job Description
Job Description Summary
The QA Manager is a versatile and dynamic member of the Quality team. The QA Manager will support the Document Control, Training and Complaint Management activities to ensure that processes and outputs adhere to applicable FDA, EU regulations, ISO 13485:2016, and other governing regulations applicable to MIM Software. They will also keep up to date with the requirements of the industry and develop a deep understanding of company processes to build a robust and efficient QMS to support the business. The QA Manager is responsible for adherence to the MIM Software Quality System.

As a critical member of the team, you will ensure adherence to the MIM/GE HealthCare Quality Management System and regulatory requirements, including 21 CFR 820, ISO 13485, and MDSAP. By employing strong critical thinking and influencing skills, you will work cross-functionally to ensure robust quality decisions. In this role, you will have a direct impact on ensuring patient safety, audit readiness, and the commercial delivery of MIM Software/ GE HealthCare systems.

Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.

Job Description

Roles and Responsibilities:
  • Ensure QMS processes such as Document Control, Complaint Management, Post-Market activities, CAPA, Training, etc meet all applicable quality & regulatory standards.
  • Write, update, and review quality documents, procedures, policies and business processes ensuring on-going compliance with current regulations, standards and applicable certifications.
  • Assist and lead in investigating nonconformities and use appropriate tools to determine the root cause.
  • Develop product knowledge to make informed decisions that influence product quality and safety.
  • Support audits by promptly delivering complete and accurate records.
  • Work with other stakeholders in the company to track and monitor successes and pain points of QMS processes.
  • Implement improvements to drive compliance, quality, and efficiency of these processes.
  • Participate in risk assessments, risk mitigation strategies and risk management plans, provide review/approval as needed.
  • Assist during audits in the room (supplier, critical supplier, notified body, or otherwise)
  • Proficient knowledge of MIM's product portfolios and Primary Products and classifications.
  • Stay current with the latest guidance documents, regulatory requirements, and industry best practices.
  • Assist in other areas of the QMS as directed by the manager.


Required Qualifications
  • Bachelor's degree from an accredited university or college.
  • At least 7 years of relevant experience in Quality Assurance in a regulated industry, either Medical Devices or Pharmaceuticals, preferably with Software as a Medical Device (SaMD)
  • Demonstrated understanding of Medical Device Quality Management System requirements and regulatory requirements, including but not limited to FDA CFR 21 820, ISO 13485, and MDSAP.
  • Demonstrated experience in leading and managing a team effectively.
  • Demonstrated ability to collaborate effectively and resolve conflicts.


Desired Characteristics:
  • Experience in Quality Assurance or Quality Engineering within the Medical Device or Pharmaceutical industry, or in Design Engineering or Manufacturing Engineering in the Medical Device field.
  • Demonstrated expertise in root cause analysis.
  • Strong influencing skills and ability to clearly communicate the requirements to cross-functional teams.
  • Exceptional critical thinking, problem-solving, root-cause analysis, and process improvement skills.
  • Proficiency in managing multiple priorities effectively.
  • Thrives in a dynamic environment and is comfortable navigating change
  • Takes initiative, manages time effectively, and is motivated to achieve goals without constant oversight. You're proactive in identifying opportunities and solving problems independently.


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

Relocation Assistance Provided: No

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
Net Income
$5.7 billion
Founded
1892
5 Year Trend
-9.1%
Revenue
$79.6 billion
NASDAQ

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