Director of Quality - San Diego, United States - BIOSERO

BIOSERO

Verified Company

San Diego, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Do you want to support scientific research that fuels innovation in healthcare, therapeutics, agriculture, and more?

Do you want to enable the world's top scientists to deliver impactful solutions faster?
Do you believe that the best team wins?
Do you thrive on providing innovative solutions to unique challenges?
Do you enjoy a fastpaced environment requiring flexibility and adaptability??

If so, we would like to meet you.

About Us
Biosero is the leader in life science robotic automation and integration.

Our award-winning no-code software tools enable vital research to be done quickly while freeing scientists to address additional scientific challenges.

Our solutions are placed in top laboratories worldwide, including the top pharmaceutical, agricultural, clinical, diagnostics, and biotech companies. Our work impacts the world by accelerating productivity, discovery, andcures. Our team is passionate about our mission to enable discoveries by coupling our software platforms with data and robotics. We have been voted the best place to work for many years.

As an equal opportunity employer, we do more than accept difference.

We celebrate diversity, we support employees from a wide range of backgrounds, and we benefit from the added creativity and richness that these differences bring to our offices and community.

We pride ourselves on having a collaborative environment where everyone?s talents and opinions contribute to the greater good and are always recognized.

What You Will Do

ONSITE ROLE
The Director of Quality manages the development, implementation, and maintenance of Biosero?s Quality Management System (QMS) and processes.

This position will interface with associates across the organization including engineers, scientists, technicians, software developers, and our business and leadership teams, ensuring compliance with company Quality standards, customer requirements, and global regulations.

Responsibilities

Administer and serve as leader of the Biosero Quality Management System (QMS)
Establish overall short

- and long-term Quality strategy and objectives.

Conceive, document, and train QPs, SOPs, and work instructions across company disciplines.
Monitor Quality objectives & performance; provide regular reports to Executive leadership.
Ensure that Biosero?s work product adheres to relevant industry standards and customer requirements (ISO9001, CE, 21CFR Part 11, ISO27001).
Stay informed about regulatory changes and ensure continued compliance with relevant guidelines.
Serve as company lead for third party regulatory audits and customer audits, queries, and inspections.
Serve as the company focal point for Sustainability initiatives, audits, queries, and guidance, and also act as the liaison to BICO Sustainability efforts.
Define standards and support the team in maintaining appropriate Quality documentation, including Quality Procedures, test protocols, reports, and compliance records.
Conduct risk assessments to identify potential quality issues and work with the team to develop mitigation strategies.
Lead risk assessments tied to regulatory certifications (e.g. CE mark).
Establish standards and processes for Supplier Quality management and oversight.
Define inspection processes and tracking methods.
Perform audits of critical suppliers.
Lead Biosero Supplier Quality Team, methodically driving improvement.
Serve as the voice of Quality at Biosero, responding to client inquiries and leading client audits.
Develop and lead customer complaint handling program.
Train employees on Quality processes and foster a culture of Quality consciousness and compliance.
Drive continuous improvement initiatives to enhance overall Quality System effectiveness and efficiency.
Performs all other duties as assigned.

Qualifications

10+ years of relevant work experience in Quality and Operational Excellence in a complex technical organization
Experience defining and building a QMS from its early stages
Knowledgeable in international quality standards (ISO9001, CE, 21CFR Part 11, ISO27001), certifications, and audits
Bachelor?s degree or higher in a field related to Quality Systems such as Quality Management, Engineering, Business Administration, or other related field
Relevant certifications for ISO or ASQ are desirable

Required Skills:

Experience with ISO 9001, 21CFR Part 11, ISO27001, and CE certification requirements; familiarity with QSR, ISO 13485 a plus
Prefer experience in Quality methods and tools like value stream analysis, 5 Why?s analysis, Kaizen, FMEA, 8D, Ishikawa diagrams, etc.
Experience with ERP systems a plus
Handson team player with a continuousimprovement mindset and sense of ownership and urgency
Outstanding attention to detail and strong organizational skills
Able to thrive in a rapidly growing startupcompany environment
Proven leader; able to work with limited supervision
Excellent communi