Senior Quality Control Specialist

Description

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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.      

Job Purpose:

The Senior Quality Control (QC) Specialist supports Biolinq’s quality objectives by reviewing production records, ensuring   documentation accuracy, and maintaining compliance with regulatory and internal standards. This role helps drive continuous improvement, supports audit readiness, and collaborates with cross-functional teams to uphold product quality throughout the production process.

   Duties and Responsibilities: 

• Conduct thorough reviews of Device History Records (DHRs) to verify compliance with SOPs, work instructions, and regulatory requirements (ISO 13485, 21 CFR Part 820, etc.).
• Perform quality control inspections on products, including in-line checks, label verification, and final goods assessment.
• Lead regular production line audits, proactively identifying compliance risks and escalating issues as appropriate.
• Collaborate with Manufacturing and Quality teams to resolve discrepancies, implement corrective actions, and drive continuous improvement.
• Support audit preparation activities, including documentation review, gap analysis, and readiness assessments for production areas
• Document and report quality metrics related to DHR review and audit readiness.
• Ensure ongoing compliance with evolving regulatory and quality system requirements
• Performs additional duties as assigned. 

Requirements

• Bachelor's degree in a related field and 3-5 years of relevant experience; OR high school diploma/GED and 7-10 years of relevant experience in a regulated medical device manufacturing environment.
• Demonstrated expertise in DHR review, regulatory compliance, quality system requirements, and audit preparation. 
• Familiarity with Quality Management Systems, Enterprise Resource Planning systems, and equipment management tools (e.g., MasterControl, NetSuite/Oracle ERP, BMRAM). 
• Ability to work collaboratively across departments
• Strong analytical skills, attention to detail, and problem-solving abilities. 
• Excellent verbal and written communication skills. 

Working Conditions:

• Work is primarily performed in a production (Clean Room) and office environment.

Physical Requirements:

•  While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee may occasionally lift/or move up to 15 pounds.

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: $90,000 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 [email protected]