Quality Assurance Analyst II

Socket.dev; San Diego (CA); On-site; USD 80,000 - 95,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Health Savings Account

Flexible Spending Account

Life insurance

Long-term disability insurance

401(k) plan

Holidays

Paid time off

Job summary

Biolinq is actively seeking a Quality Assurance Analyst II to join the Quality team. The role focuses on processing change orders from cross-functional teams and setting up training materials related to those changes.

You will manage document numbers, logbooks, and records, contribute to supplier management and CAPA/NCMR events, and support internal and external audits. Strong attention to detail and clear communication are essential.

Qualifications

• Associate degree and 4 years of experience; Bachelor’s degree preferred. Or an equivalent combination of experience and education.
• Biological, Chemistry, Quality or Engineering discipline preferred
• Minimum of 3 years’ experience in Quality Document Control
• Minimum of 3 years’ experience in a medical device, biotech or pharmaceutical setting, FDA and or ISO regulated industry required; MDSAP or MDR experience preferred
• Experience with electronic quality management systems; MasterControl highly desirable
• Critical thinking skills
• Ability to interface with multiple departments in a fast-paced environment
• Excellent written and verbal communication skills

Responsibilities

• Process Change Orders in an electronic quality management system; revise as required.
• Create and assign training lessons; attach documents and quizzes as applicable.
• Organize, collect and file paper records related to manufacturing and Quality.
• Communicate with multiple teams to prioritize change orders.
• Control the assignment and collection of Logbooks.
• Assign manufacturing device history record and document numbers.
• Conduct in-person training on Quality topics.
• Conduct employee onboarding training on Quality topics.
• Create or revise procedures or work instructions.
• Conduct investigations for NCMR or CAPA events.
• Contribute to Supplier Management; update ISO certificates and supplier spreadsheets.
• Pull reports for departmental metrics.
• Assist the Quality team in external and customer audits.
• Other tasks as assigned

Skills

Attention to detail

Analytical skills

Problem solving

Communication skills

Education

Associate degree

Bachelor's degree

Equivalent combination of experience and education

Tools

MasterControl

Job description

Description

WARNING about fake job posting scams.

There has been a recent wave of scams whereby third parties post fake job openings using a bogus email address that resembles [e-mail]. Under the guise of asking you to fill out an application, the scammers are attempting to gather your personal information. See the Federal Trade Commission’s warning on this topic at: https://consumer.ftc.gov/articles/job-scams

The only official source for actual Biolinq job postings/openings is at www.biolinq.com/careers. While other job sites (such as LinkedIn, Indeed or Glassdoor) may pull from Biolinq’s careers web page, you should visit www.biolinq.com/careers to verify the accuracy of the openings found on third party web sites.

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

This is a key role as part of the Quality team interacting with multiple departments at Biolinq. This highly visible role within the Quality department will focus on processing change orders from cross-functional teams of engineers in chemistry, software, hardware, manufacturing, and quality and setting up the required training associated with the document contained within the change orders. They will be responsible for additional document control activities such as assigning document and DHR numbers, organizing and filing records, and logbook control. They may also contribute to the supplier management program and management of NCMR and CAPA events. This role requires significant attention to detail, great communication skills, and the ability and critical thinking skills to prioritize competing projects.

• To be successful as a Quality Assurance Analyst II, you should demonstrate strong attention to detail and have analytical and problem-solving abilities. The ideal candidate must be able to interpret and implement quality assurance standards and provide accurate and comprehensive feedback to colleagues.

Duties and Responsibilities

• Process Change Orders in an electronic quality management system, performing review for compliance to work instructions and working with submitters to revise change orders as required.
• Create and assign training lessons in an electronic quality management system, ensuring the correct documents are attached to the training lessons, creating course quizzes as applicable, and assigning lessons to the appropriate employees.
• Organize, collect and file paper records associated with manufacturing and Quality
• Communicate effectively with multiple teams to prioritize change orders
• Control the assignment and collection of Logbooks
• Assign manufacturing device history record and document numbers
• Conduct in-person training sessions for employees on various topics
• Conduct employee on-boarding training on Quality related topics
• Create and or revise procedures or work instructions in areas of focus
• Conduct investigations as assigned for NCMR or CAPA events
• Contribute to the Supplier Management process; update ISO certificates, update supplier spreadsheet, etc.
• Pull reports for departmental metrics
• Assist the Quality team in hosting external and customer audits
• Other tasks as assigned

Requirements

• Associate degree and 4 years of experience; Bachelor’s degree preferred. Or an equivalent combination of experience and education.
• Biological, Chemistry, Quality or Engineering discipline preferred
• Minimum of 3 years’ experience in Quality Document Control desired
• Minimum of 3 years’ experience in a medical device, biotech or pharmaceutical setting, FDA and or ISO regulated industry required; MDSAP or MDR experience preferred
• Experience with electronic quality management systems as well as paper based systems. Experience with MasterControl highly desirable
• Critical thinking skills
• Ability to interface and communicate with multiple departments and work in a fast-paced, multi-disciplinary environment
• Capacity to manage multiple tasks and communicate clearly to the team; excellent written and verbal communication skills
• Experience with internal and external audit activities a plus

Working Conditions

• General Office and Laboratory.

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: $80,000 to $95,000 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 [e-mail]