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Senior Quality Assurance Specialist
1 month ago
We are seeking a highly skilled Senior Quality Engineer to join our team at Element Biosciences. This role will play a pivotal part in providing quality engineering expertise and support for our on-market products, assessing and managing the Quality Management System (QMS) performance and improvement to ensure our processes and products meet defined requirements.
This is an excellent opportunity for someone who is passionate about being a leader that can work with significant autonomy and independent judgement to achieve our Quality goals and lead continuous improvement projects with cross-functional teams.
We are looking for candidates with a solid background in life sciences and experience with developing strong working relationships with both internal and external customers to influence and enable an effective Quality Culture.
The successful candidate will be responsible for supporting all aspects of Quality System for on-market products, including Non-Conformance Reports, Corrective and Preventative Actions, Complaint Investigations, Change Management, Risk Assessments, and support of internal and/or external audits.
They will also provide quality support on internal failure investigations and lead / facilitate supplier investigations, ensuring corrective and preventive actions are effective and implemented in a timely manner.
Additionally, they will provide quality input on internal and external test method / component / equipment qualifications, including review of test plans / protocols and reports, guidance on inspection requirements and sampling plans, and risk assessments.
The ideal candidate will have a Bachelor's degree in Engineering, Biology, Molecular Biology, Microbiology, or related science field, and a minimum of 5 years' experience in the life sciences industry or fast-paced start-up.
They will also have experience with ISO9001, ISO13485, 21CFR820, 21CFR 211, or other regulated industries, and be able to understand quality systems and implement risk-based, systemic changes to enhance product quality and business efficiency in a scalable manner.
Strong interpersonal skills, ability to collaborate closely with suppliers and internal Production and Operations staff of varying levels, and self-motivation are essential for this role.
The successful candidate will also have strong analytical skills, reporting, and data analysis, and be able to work in a fast-paced and technically challenging environment where adaptability and drive are critical to success.
We offer a competitive salary range of $97,000 - $118,000, stock options, discretionary annual bonus, no-cost health insurance plans, 401k with company match, and flexible paid time off.
We are an equal opportunities employer and welcome applications from all qualified candidates.
