Senior Quality Engineer
Senior Quality Engineer
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1 Vacancy
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 Cytiva 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.
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines new medicines and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us working on challenges that truly matter with people that care for each other our customers and their patients. Take your next step to an altogether life-changing career.
Learn about the Danaher Business System which makes everything possible.
The Lead Quality Assurance Engineer for Cytiva is responsible for various aspects of the QMS including change control risk management non-conformances CAPAs complaints and field actions.
This position reports to the Sr. Quality Manager for Upstream and Fluid Management within the Quality Assurance team located in Marlborough MA and will be an onsite role 3-5 days per week.
In this role you will have the opportunity to:
Act as a subject matter expert for Change Management/Change Control process supporting other QMS functions such as Nonconformance and CAPA process Complaint and Field Action process as well as the Product Life Cycle Management
Establish and maintain site/business unit level processes and procedures and responsible for following the Global process and procedures effectively within our Quality System.
Collaborate with stakeholders across several business functions providing excellent customer service while creating and routing complex changes in our Quality System
Lead or support quality and compliance projects as requested and perform other assigned duties as needed.
The essential requirements of the job include:
Bachelors degree required; additional training/education preferred through ASQ (or relevant society) and/or Masters level program
At least 8 years relevant experience industry experience (e.g. GMP medical device pharmaceutical) required
At least 5 years relevant QMS experience dealing with investigations CAPA change control risk management.) required; 6-8 years preferred
Extensive experience with cGMP and/or ISO 13485 including documentation audit nonconformance and CAPA
Excellent verbal written and presentation skills with the ability to communicate business issues clearly in English
It would be a plus if you also possess previous experience in:
Experience with supporting change control systems (ECR / ECO) and risk management (FMEA)
Analyzing and processing data with various statistical tools and drawing relevant conclusions
Working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
The salary range for this role is 97800- 155000. This is the range that we in good faith believe is the 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 comprehensive package of benefits including paid time off medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. 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 and may be modified at the Companys sole discretion consistent with the law.
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. We value diversity and the existence of similarities and differences both visible and not found in our workforce workplace and throughout the markets we serve. Our associates customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform crucial job functions and to receive other benefits and privileges of employment. Please contact us at to request accommodation.
Required Experience:
Senior IC
Employment Type
Full-Time
