Lead Principal Specialist, Quality Assurance and Regulatory Compliance Service
Lead Principal Specialist, Quality Assurance and Regulatory Compliance Service
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Job Description
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology
At Leica Biosystems one of Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.
Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.
At Leica Biosystems were not just shaping the future of cancer diagnostics were transforming lives. Our mission of Advancing Cancer Diagnostics Improving Lives is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis we empower clinicians with innovative reliable solutions so they can give patients timely accurate answers when they need them most. When you join Leica Biosystems youre not just taking a job; youre becoming part of a passionate team that knows every moment matters when it comes to cancer. Youll help develop diagnostic solutions that turn anxiety into answers and aid the acceleration of next-generation life-changing therapies. Surrounded by a diverse and collaborative global community youll be inspired each day to stretch grow and make an impact.
Learn about the Danaher Business System which makes everything possible.
The Lead Principal Specialist Quality Assurance and Regulatory Compliance Service role will provide Quality & Regulatory support and leadership to maintain improve and support processes to ensure compliance with applicable regulations and standards executed globally at the Selling Unit (SU). This individual acts as a pivotal point of contact and alignment between the Leica Biosystems (LBS) SUs and the Leica Biosystems Business Units (BUs) to ensure compliance. This position will also lead the quality activities at the SU service and repair shop out of the Richmond IL location.
Major Responsibilities
- Establish and maintain Quality requirements at the LBS SUs Globally including training (example: complaint handling adverse event escalation recall product classification and product claims) execution of field action activities and ensuring compliance of the Service and Installation records.
- Establish and maintain Quality requirements at the Richmond SU Service and Repair shop including proper processing of the medical devices and training to the QMS procedures.
- Lead as the core representative for internal and external audits of both the SU QMS and the Richmond SU Service and Repair Shop
- Serve as Project Manager for designated improvement projects.
- Effectively use Danaher Business System (DBS) tools to drive continuous improvement.
Skills/Experience
- Bachelors degree in science medical or technical field required
- 7 years work experience with increasing responsibility in medical device/IVD Quality Assurance showing extensive knowledge of medical device quality systems including but not limited to 21 CFR 820 MDSAP ISO 14971 and ISO 13485 required
- Experience with problem-solving and continuous improvement tools required
- Specific experience in driving compliance of quality systems required.
- Exceptional communication skills (verbal/written/presentation/relationship building) with ability to work collaboratively with customers cross-functional project teams and regulators.
- Certifications preferred: Quality Management Quality Auditor Lead Auditor Six-Sigma Black Belt Quality Engineer
Travel % of Travel include approximate overnight stays per week
- Travel expectationsforthis roleislimitedand mainly flexible (<20%)
Location:
- Home officeis at Richmond IL. This is an onsite role but will be working with individuals globally.
This job description in no way states or implies that these are the only duties to be performed by this employee. The incumbent is expected to perform other duties necessary for the effective operation of the department or unit. This job description may be changed at any time.
The salary range for this role is between $120000-$130000. This is the range that we in good faith believe isthe range of possible compensation for this role at the time of this posting. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer a comprehensive package of benefits including paid time off medical/dental/vision insurance and RetirementBenefits to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested anddeterminable. The amount and availability of any bonus commission benefits or any other form of compensation and
benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid andmay be modified at the Companys sole discretion consistent with the law.
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Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.
For more information visit .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race color national origin religion sex age marital status disability veteran status sexual orientation gender identity or other characteristics protected by law.
The U.S. EEO posters are available here.
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process to perform essential job functions and/or to receive other benefits and privileges of employment please contact:1- or .
Required Experience:
Staff IC
Employment Type
Full-Time
