Job Purpose:

The Senior Quality Engineer is responsible for leading Quality Engineering activities with a strong emphasis on design controls, product risk management, and integration of clinical and field feedback into design and quality decisions.  This is a hands-on role requiring independent judgment, technical depth, and the ability to influence cross-functional teams to ensure product safety, performance, and regulatory compliance.

Duties and Responsibilities:

• Partner closely with R&D and engineering teams to ensure design control activities are properly executed and documented, including development and review of design inputs, outputs, verification and validation strategies, and design changes.
• Support development of specifications, test methods, and acceptance criteria to verify and validate design choices using appropriate statistical methods.
• Lead and support product risk management activities, including hazard analyses, DFMEA, PFMEA, and linkage of risk controls to design and process requirements.
• Lead Quality evaluation of clinical device observations and product complaints, including determination of investigation requirements, assessment of risk and design impact, and ensuring appropriate escalation (e.g. risk file updates, design changes,        CAPAs). 
• Support manufacturing quality activities, including review of Build Requests, risk-based review of Device History Records (DHRs), and execution of manufacturing line audits to verify compliance with approved procedures and specifications.
• Support supplier quality activities, including supplier evaluation, qualification, and monitoring, review of supplier nonconformances and investigations, and participating in supplier audits, as needed.
• Support maintenance and continuous improvement of the Quality Management System (QMS), including updating SOPs and presenting key Quality metrics as part of Management review.
• Support internal and external audits, serving as a key Quality representative during   regulatory inspections and notified body audits.

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About the Company

Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health. 

Qualifications:

•  BS Degree or higher in Mechanical, Electrical, Chemical, Biomedical Engineering or related technical discipline
• 5+ years experience in a regulated medical device development environment (i.e. 510(k), PMA) 
• Demonstrated working knowledge of medical device quality systems and regulations, including design controls (21 CFR 820.30), ISO 13485, and associated practices such as Risk Management (ISO 14971) and Design History Files (DHF).
• Proven ability to apply statistical and data-driven methods to support design verification, validation, and quality decision-making, including understanding of sample size rationale, variability, confidence, and acceptance criteria.
• Experience using statistical and analytical tools (e.g., Excel, JMP, Minitab, R)
• Highly proficient with Windows-based business applications, including effective use of Excel for data analysis and Word/PowerPoint for preparation of technical and quality documentation.
• Strong organizational and communication skills, with the ability to manage multiple priorities, exercise sound judgment, and clearly communicate complex concepts.
• Highly methodical, detail-oriented, and comfortable operating in a fast-paced, evolving development environment. 

Working Conditions:

• Office-based work environment with regular interaction in laboratory, manufacturing, and production areas as needed to support quality, engineering, and manufacturing activities.
• Standard work schedule is full-time, daytime business hours
• 0-10% travel anticipated for this role

Physical Requirements:

• Ability to sit, stand, and walk for extended periods during the workday, including time spent in office, laboratory, and manufacturing environments.
• May be exposed to laboratory or manufacturing environments, including moderate   noise levels, moving mechanical parts, and controlled exposure to chemicals and biological materials, in accordance with established safety procedures.
• Use of personal protective equipment (PPE) may be required when working in manufacturing or laboratory areas.
• Ability to lift and/or move materials or equipment up to approximately 15 pounds on an occasional basis.

BENEFITS

Medical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO. 

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.

As part of our efforts to ensure fair and equal pay based on merit, Biolinq supports pay transparency internally and during the recruitment process.  The U.S. base salary range reasonably expected to be paid for this role is: $85,000 to $110,000 per year.  We may ultimately pay more or less than the posted range.  Actual compensation packages are commensurate with experience and based on a variety of factors that are unique to each candidate including, but not limited to: skill set, depth of experience, education, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries for the job across the U.S.  The total compensation package for this position may also include an annual performance bonus and/or other applicable incentive compensation plans.  Biolinq also offers a comprehensive package of benefits including paid time off (vacation, holidays, sick time, parental leave), medical/dental/vision insurance, and 401(k) to eligible employees, subject to the terms and conditions of the applicable plans and any written agreement between the parties.  Your recruiter can share more about the total compensation package during the hiring process.  

Please note: The information contained herein is not intended to be an all-inclusive list of duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. 

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Biolinq Talent Acquisition at Careers@biolinq.com