Overview
Senior Quality Engineer role at Cytiva. 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.
Essential Requirements
Bachelor's degree required; additional training / education preferred through ASQ (or relevant society) and / or Master's level programAt least 8 years relevant experience in industry (e.g., GMP medical device, pharmaceutical) requiredAt least 5 years relevant QMS experience dealing with investigations, CAPA, change control, risk management; 6-8 years preferredExtensive experience with cGMP and / or ISO 13485 including documentation, audit, nonconformance and CAPAExcellent verbal, written, and presentation skills with the ability to communicate business issues clearly in EnglishPreferred Qualifications
Experience with supporting change control systems (ECR / ECO) and risk management (FMEA)Analyzing and processing data with various statistical tools, and drawing relevant conclusionsWorking with cross-functional teams and facilitating teams to identify and implement solutions to complex problemsSalary range noted in posting : 97,800 - 155,000. The job is also eligible for bonus / incentive pay. We offer a comprehensive package of benefits including paid time off, medical / dental / vision insurance, and 401(k) to eligible employees.
Note : The information presented here is based on the posting and may be modified. Equal opportunity and compliance statements apply. If reasonable accommodation is needed to participate in the job application or interview process, please contact : 1-202-419-7762 or applyassistance@danaher.com.
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