Element Biosciences
Overview
At Element Biosciences, we are passionate about our mission to empower the scientific community with more freedom and flexibility to accelerate our collective impact on humanity. We have built a highly efficient product-driven organization where employees can learn, grow, and thrive in a challenging but encouraging environment. We are committed to scientific integrity, collegiality, honesty, objectivity, and openness. We are seeking an experienced
Senior Quality Engineer
who will play a pivotal role in maturing Element’s Quality Management System (QMS) towards ISO 13485 compliance and provide quality engineering expertise on Element’s on-market products. This is an incredible 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 medical devices (Class I-II). This role will report to the Manager, Quality Engineering and will be a San Diego based role. Essential Functions and Responsibilities
Spearhead development and continuous improvement of QMS processes, including internal audits, design and process/equipment/software validation, and management review Lead/conduct internal audits and prepare/coach teams on audit best practices to drive toward compliance Interpret regulations and requirements to lead efforts related to Risk Management, Verification & Validation, Design History File (DHF), Design Master Records (DMR), and Device History Records (DHR) Support activities related to Non-Conformance Reports (NCRs), deviations, complaint investigations, and change management to ensure QMS requirements are met As needed, support supplier management activities including onboarding/qualification, quality investigations, supplier business reviews, and ongoing monitoring Education and Experience
Bachelors degree in Engineering, Biology, or related science field (an equivalent combination of experience and education may be considered) A minimum of 5 years’ experience, preferably in the medical device (Class I-II) or other regulated industry Experience with ISO13485, ISO 14971, IEC 62304, 21CFR820, 21CFR 211 is strongly preferred Experience leading internal and external audits is strongly preferred Experience with a wide range of validation including design, process, equipment, and software is strongly preferred Ability to work in a fast-paced and technically challenging environment where adaptability and drive are critical to success Strong interpersonal skills with the ability to collaborate closely with suppliers and internal stakeholders of varying levels to drive Quality System improvements Demonstrates an ability to work independently and as part of a team Self-motivated and able to organize and prioritize multiple tasks Strong inclination and passion for continuous improvement Strong analytical skills, reporting, and data analysis are strongly preferred Experience working with electronic Quality Management Systems and manufacturing-related business systems, like ERP and MES, is preferred ISO13485 Lead Auditor certification and ASQ CQE certification is a plus Physical Requirements
Frequently moves boxes weighing up to 20 pounds Location
San Diego, California Travel
Domestic travel up to 10% Job Type
Full-time/Exempt Base Compensation Pay Range
$110,000 - $145,000 Benefits
In addition to base compensation noted above, you will be eligible for stock options, discretionary annual bonus, no-cost health insurance plans, 401k with company match, and flexible paid time off. Please note: Base compensation will depend on multiple factors, including geographic location, qualifications, and experience. Equal Employment Opportunity
We foster an environment such that all people are afforded the freedom to pursue their passions without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.
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At Element Biosciences, we are passionate about our mission to empower the scientific community with more freedom and flexibility to accelerate our collective impact on humanity. We have built a highly efficient product-driven organization where employees can learn, grow, and thrive in a challenging but encouraging environment. We are committed to scientific integrity, collegiality, honesty, objectivity, and openness. We are seeking an experienced
Senior Quality Engineer
who will play a pivotal role in maturing Element’s Quality Management System (QMS) towards ISO 13485 compliance and provide quality engineering expertise on Element’s on-market products. This is an incredible 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 medical devices (Class I-II). This role will report to the Manager, Quality Engineering and will be a San Diego based role. Essential Functions and Responsibilities
Spearhead development and continuous improvement of QMS processes, including internal audits, design and process/equipment/software validation, and management review Lead/conduct internal audits and prepare/coach teams on audit best practices to drive toward compliance Interpret regulations and requirements to lead efforts related to Risk Management, Verification & Validation, Design History File (DHF), Design Master Records (DMR), and Device History Records (DHR) Support activities related to Non-Conformance Reports (NCRs), deviations, complaint investigations, and change management to ensure QMS requirements are met As needed, support supplier management activities including onboarding/qualification, quality investigations, supplier business reviews, and ongoing monitoring Education and Experience
Bachelors degree in Engineering, Biology, or related science field (an equivalent combination of experience and education may be considered) A minimum of 5 years’ experience, preferably in the medical device (Class I-II) or other regulated industry Experience with ISO13485, ISO 14971, IEC 62304, 21CFR820, 21CFR 211 is strongly preferred Experience leading internal and external audits is strongly preferred Experience with a wide range of validation including design, process, equipment, and software is strongly preferred Ability to work in a fast-paced and technically challenging environment where adaptability and drive are critical to success Strong interpersonal skills with the ability to collaborate closely with suppliers and internal stakeholders of varying levels to drive Quality System improvements Demonstrates an ability to work independently and as part of a team Self-motivated and able to organize and prioritize multiple tasks Strong inclination and passion for continuous improvement Strong analytical skills, reporting, and data analysis are strongly preferred Experience working with electronic Quality Management Systems and manufacturing-related business systems, like ERP and MES, is preferred ISO13485 Lead Auditor certification and ASQ CQE certification is a plus Physical Requirements
Frequently moves boxes weighing up to 20 pounds Location
San Diego, California Travel
Domestic travel up to 10% Job Type
Full-time/Exempt Base Compensation Pay Range
$110,000 - $145,000 Benefits
In addition to base compensation noted above, you will be eligible for stock options, discretionary annual bonus, no-cost health insurance plans, 401k with company match, and flexible paid time off. Please note: Base compensation will depend on multiple factors, including geographic location, qualifications, and experience. Equal Employment Opportunity
We foster an environment such that all people are afforded the freedom to pursue their passions without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.
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