Reporting directly to the Vice President, Manufacturing and Supply Chain, the Director, Quality and Regulatory, is a key management position responsible for establishing and ensuring compliance of the company’s overall Quality Assurance, Regulatory Compliance, and Regulatory Standards strategies and activities.
This individual will act as the firm’s worldwide quality leader and regulatory compliance officer – responsible for quality systems and regulatory affairs.
The successful candidate will initially be operating in a very large, fast-paced start-up environment – with the opportunity to define and scale core assurance and compliance processes/systems from scratch.
As part of our team, your core responsibilities will be:
1) Regulatory and Product Standards Compliance
Ensure compliance with national and international standards, regulations and legislation in all applicable markets; including, and not limited to, applicable revisions of ISO 9001, ISO 13485, CMDCAS, CE/MDD, FDA, SFDA (China), ANVISA (Brazil) and Environmental Health and Safety standards.
Ensure that regulatory filings with proper agencies are submitted on a timely basis as required by regulation.
Direct the company’s quality management system and serve as the Company’s Regulatory Management Representative – and Compliance Officer.
Demonstrate effective leadership and strategic planning and creativity skills in environments where regulatory compliance best practices need to be developed – and implemented.
Proven ability to interpret documents of significant complexity, including external standards, design inputs and verification/validation protocols.
Audit: Act as the top audit escort for external audits. Oversee comprehensive internal audit program, including tracking and timely closure of non-compliances.
2) Quality Assurance
Design and direct training and internal communication programs to build a culture of quality that is comprehensive and well-understood.
Plan, develop and implement breakthrough strategies for Quality Assurance that supports corporate objectives.
Partner with Research, Development, Manufacturing and Support Operations to ensure Quality Assurance best practices are appropriately
3) Overall Cross-Functional Collaboration
Partner with Engineering and Operations on new product introductions (NPI) to ensure functionality, quality and time-to-market targets are met – with complete regulatory compliance.
MBA and/or MS in Quality or technical (engineering, physics) field
10+ years of experience in medical device industry quality assurance and regulatory affairs management.
Ability to assess future customer satisfaction requirements and to implement the resulting Quality and Regulatory resource capabilities that will enable Quantum-Si to efficiently scale from $0M-$100M+ annual sales rate
Working experience in Statistical Process Control (SPC), Total Quality Management (TQM) and LEAN.
Expert-level Excel skills
Ideally, you also have these skills/experiences/attributes:
Proven ability to assess organizational capabilities and recruit, train and develop high performing Quality and Regulatory teams
An enthusiastic, high-energy and motivating leader who is visibly passionate, capable of galvanizing an organization, and who possesses strong facilitative leadership skills
An exceptional communicator who can write, present and effectively adjust messages to meet individual audiences and organizations
Consistent experience managing progressively larger multi-$M Quality and Regulatory budgets
You Deeply Identify with Core Quantum-Si Values:
Efficient & Speedy - you get work done in a fraction of the time as industry peers
Intellectually Curious - you are thoughtful & inquisitive; people enjoy working with you because they learn from you
Mission-Driven & Committed - you are passionate about the company's purpose and are immensely productive
Team Oriented - you celebrate and take joy in the success of others on the team
Telecommuting is allowed.
Internal Number: #001 QS-I DirQ&R
About Quantum-Si Corporation
Quantum-Si is pioneering a new generation of technology to create the market of Next Generation Protein Sequencing (NGPS). Similar to Next Generation DNA Sequencing (NGS), which gave us a blueprint of what could happen by studying our DNA, NGPS enables an unbiased view of the proteome through improved scale, resolution, and sensitivity leading to better understanding of disease and improved general health.
We operate at the intersection of biochemistry, chemistry, hardware, molecular biology, photonics, semiconductor chips, and software with a goal to drive a digital transformation of a $36 billion dollar proteomics market.
Join us on the journey to transform healthcare, motivated by the idea that the products you work on will change the lives of millions of people around the world.