Visibly Manager of Quality Assurance Remote · Full time

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Who We Are

Visibly is a Chicago-based healthcare technology company founded in 2012, building digital vision care solutions that enable patient choice and provider capacity. Online vision testing is just the start; Visibly envisions a world where technology enables patients and doctors to connect easily and make other aspects of vision care more convenient and accessible to everyone. 

We launched the first online refractive eye test that delivers a physician-issued prescription for glasses or contact lenses and we are the first FDA-cleared online visual acuity test on the US market. (See our announcement here)

Summary of Position

The Manager of Quality Assurance reports to the Vice President of Quality Assurance and Regulatory Affairs. This role is responsible for Quality Assurance activities related to the development, submission, deployment, and on-market support of Software as a Medical Device (SaMD) products.

Essential Duties and Responsibilities

• Update QMS procedures, work instructions, and forms to meet increased compliance requirements based on planned new market entry plans being executed regulatory affairs
• Lead product complaint investigations and resolutions, includes advising on needed actions
• Partner with the Product Development team to ensure timely and complete design reviews, including all applicable documentation (e.g. V&V, FMEA, and RMR)
• Coordinate Material Review Board (MRB) meetings to ensure proper lifecycle of CAPA’s and NCR’s
• Complete of Post Market Surveillance (PMS) activities, including Post Market Surveillance Update Reports (PSUR’s)
• Support Health Hazard Evaluation’s (HHE’s) for product recalls, field actions or market withdrawals relating to non-conforming product
• Maintain supplier management files, ensuring all new suppliers are vetted according to the internal QMS procedure
• Conduct or support all QMS audits (Internal and External) as well as resolution of any findings
• Maintain equipment management files (e.g. purchase, identification, traceability, calibration and
• disposal)
• Ensure alignment with internal staff members, and external partners and resources for QMS
• improvement projects
• Provide support for global quality and regulatory initiatives

Supervisory Responsibilities

• Currently: None
• Note: As the company grows, this position may lead a team that may include principals, analysts, specialists, and associates, as required to meet quality objectives of the company.

Competency Required for Position

• US FDA Medical Device Regulations
• ISO 13485:2016
• ISO 14971:2019
• CMDR SOR/98-282
• EU MDR 2017/745

Qualifications Required for Position

• Bachelor of Science (B.S.) degree in a Science, Technology, Engineering, or Math (STEM) field or an
• equivalent combination of education, training, and experience
• Minimum of 5-years of Quality Assurance experience in the medical device industry with a track
• record of successful ensuring a compliant QMS with notified bodies, and competent authorities.
• Minimum of 3-years of demonstrated experience leading and executing key QMS sustaining and improvement processes, CAPA’s, NCR’s, Complaint investigation and closure, Supplier management, and PMS activities.
• Knowledge of regulatory processes, including domestic and international submissions, change impact assessments, product labelling requirements, and product instructions for use.
• Ability to interpret and disseminate medical device regulations and standards (e.g. US FDA Title 21 CFR Part 820 Quality System Regulation, the ISO 13485:2016 international standard for Medical Device Quality Management Systems, and IEC 62304 for Medical Device Software, and IEC 62366 for Usability).
• Clear and concise written and verbal communication skills
• Desire to be hands-on at all levels of tasks
• Authorized to work in the United States

Benefits:

Just like our patients, we treat our employees with the utmost care. In addition to competitive compensation, equity packages, and performance-driven bonuses, working here is on par with the most exciting employers on the market.

• Competitive compensation
• Health insurance, medical and dental
• 401(k)
• Subsidized lunches
• Free eye prescriptions from the Visibly system
• Flexible vacation
• Work-from-home policy

*Please note: Visibly is unable to provide sponsorship or transfer any kind of Visa at this time.*

All positions at Visibly require an applicant who has accepted an offer to undergo a background check. The specific checks are based on the nature of the position. Background checks may include some or all of the following: SSN/SIN validation, education verification, employment verification, and criminal check, search against global sanctions and government watch lists, fingerprint verification, credit check, and/or drug test. By applying for a position with Visibly, you understand that you will be required to undergo a background check should you be made an offer. You also understand that the offer is contingent upon successful completion of the background check and results consistent with Visibly's employment policies. You will be notified during the hiring process which checks are required for the position.

Visibly is an Equal Employment Opportunity/Affirmative Action employer and well committed to a diverse workforce. We do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, veteran status, and basis of disability or any other federal, state or local protected class.

Pay Transparency Non-Discrimination Notice – Visibly will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

The expected base salary for this position ranges from [$72,000 - $125,000]. It is not typical for offers to be made at or near the top of the range. Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, licensure or certifications obtained. Market and organizational factors are also considered. In addition to base salary and a competitive benefits package, successful candidates are eligible to receive a discretionary bonus or commission tied to achieved results.