Quality Manager

Biolinq is a venture-backed clinical stage medical device company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. Our products are reliable, affordable and designed with a core focus on user experience. Our team is driven to develop products that will change the way patients manage their health. We are dedicated to the personal and professional growth of all our team members and strive to create a positive and creative work environment.

This is a dynamic role as part of a team of engineers and scientists developing a novel intradermal biosensor technology. You will have the opportunity to define the direction of the company's first product, from R&D, to clinical trials, to the regulatory submission process. As the Quality Manager you will be responsible for the management of Quality activities ranging from quality system compliance to product development through transfer to manufacturing. You will provide intensive, self-directed, and diversified knowledge of engineering and quality principles and practices for medical devices and accessories to the Quality Engineers and Inspectors. You lead by example as a hands-on Manager to help with tasks as necessary.

• Define, establish, and familiarize employees on industry-accepted quality standards, including design controls;
• Assist in maintaining QSR, GLP, GMP and FDA compliance standards and keeping up-to-date on current regulations and industry standards.
• Provide input and help develop specifications and test methods to verify and validate design choices in a statistically significant manner; working closely w/ engineering and scientific teams to ensure compliance with quality standards and design controls
• Manage centralized QMS
• Support and provide resources to lead risk analysis projects such as hazard analysis and DFMEA / PFMEA
• Ensure various statistical methods aimed at understanding process variability are utilized
• Provide resources to source and qualify suppliers by performing supplier assessments/audits and documenting qualifications in accordance with established operating procedures
• Prepare for audit by regulatory authorities by ensuring that all documentation is current, signed, and in compliance
• Serve as a key member of the audit team, supporting regulatory audits with agencies such as the FDA, notified bodies and state regulatory agencies (i.e. CAFDB)
• Unsure key performance indicators associated with the quality management system are defined and monitored; assist with compiling information for Management Review
• Performs other duties as required

• BS Degree or higher in Engineering or equivalent field
• 5+ years experience in a regulated medical product development environment (i.e. 510(k), PMA) or other regulated environment
• Solid experience with quality systems, including design controls (21 CFR 820.30), ISO specifications (13485), and related documentation protocols for medical devices, including compiling design history files
• Familiarity with statistical / mathematical modeling tools (i.e. Excel, Matlab, Minitab, Mathematica, Origin, R)
• Ability to interface across scientific and engineering teams and work in a fast-paced, multi-disciplinary environment
• Ability to manage multiple projects and communicate ideas clearly to the team; highly methodical and detail-oriented
• Willingness to take the lead on the implementation of quality management systems in the R&D and manufacturing environments and familiarizing all employees with quality systems, requirements, and protocols · Familiarity with process engineering / process design / development is a plus

At Biolinq we fully subscribe to the principles of Equal Employment Opportunity. It is our policy to provide employment, compensation, and other benefits related to employment based on qualifications, without regard to race, color, religion, national origin, age, sex, veteran status, genetic information, disability, or any other basis prohibited by federal, state or local law. In accordance with requirements of the Americans with Disabilities Act and applicable federal, state and/or local laws, it is our policy to provide reasonable accommodation upon request during the application process to applicants in order that they may be given a full and fair opportunity to be considered for employment. As an Equal Opportunity Employer, we intend to comply fully with applicable federal, state and/or local employment laws and the information requested on this application will only be used for purposes consistent with those laws. To the extent required by applicable law, The Company maintains a smoke- free workplace.