JOB DESCRIPTION SUMMARY
The Senior Quality Engineer will assist in managing the global quality systems and regulatory compliance strategy for invitro diagnostics (IVD), focusing on at-home and point-of-care molecular diagnostic platforms. The primary responsibilities include developing and continuously improving QMS processes to support product development, manufacturing, and business objectives, ensuring compliance with relevant government regulations and standards. This position reports to the Director of Quality and Regulatory Affairs. Please note that only qualified individuals being considered will be contacted.
ESSENTIAL FUNCTIONS
- Support development and maintenance of an effective QMS, ensuring compliance with government regulations (FDA’s QSR and other relevant country-specific regulations) and applicable standards (ISO 13485, ISO 14971, MDSAP, etc.) for IVD products
- Assist in authoring, reviewing, and revising QMS documents including quality manual, procedures, work instructions, etc.
- Collaborate with management to facilitate the implementation and ongoing effectiveness of the QMS through the use of quality policy, business and quality objectives, and quality plan activities
- Provide quality guidance on product design and development efforts, including design control aspects such as design inputs, design verification, design outputs, design validation, usability/human factors, process validation, test protocols, reports, and design transfer
- Assist in authoring, reviewing, and/or approving DHF documentation. Ensure that all relevant development phase requirements are adequately fulfilled and documented within the DHF before allowing the project to proceed further in the development process.
- Assist in the creation and maintenance of risk management documents for products under design control or for released products, including risk management plans, reports, risk analysis documents, risk management files, and FMEAs
- Assist in overseeing manufacturing and validation activities to ensure they are well-established and compliant with all relevant agency and internal quality requirements
- Collaborate with Operations and CMO during design transfer to ensure comprehensive and efficient completion of product DMR and effective knowledge transfer
- Support the management of non-conformances, CAPA, failure investigation, product disposition, deviations, customer feedback, complaint handling, field actions, product recalls, reporting, post market surveillance, and additional quality assurance tasks
- Lead and administer the Engineering Change Orders (NCOs) workflow, document control activities, and other electronic process workflows in the eQMS. Review for quality and regulatory impact in accordance with requirements from regulatory agencies and internal stakeholders.
- Coordinates internal/external audits and government agency inspections
- Aid in establishing supplier quality requirements, review supplier purchase orders to verify compliance with those requirements, and conduct supplier qualification, audits, and ongoing monitoring
- Support in defining and monitoring key quality performance metrics to ensure continuous improvement in product quality, while also establishing product quality and process metrics that effectively measure and improve performance
- Maintain strong connections with engineering, R&D, regulatory affairs, manufacturing, business development, and other functions to effectively fulfill quality-related responsibilities
- Provide guidance and training to internal eQMS users, ensuring that all employees receive tailored instruction on QMS policies and procedures pertinent to their respective roles
- Stay current with emerging scientific methods, evolving standards, regulations, and industry trends influencing the organization. Propose adjustments or enhancements to processes, systems, or designs in response to these developments.
- Performs other duties and responsibilities as assigned
QUALIFICATIONS
(Required)
- Bachelor's degree, preferably in engineering or science, or related field plus a minimum of six (6) years of practical experience as a Quality Engineer supporting a commercially available Class II/III active medical device (preferably IVD), or an equivalent combination of education and experience
- Strong working knowledge of quality system regulations and standards, including FDA’s QSR (21 CFR Part 820), ISO 13485, ISO 9001, ISO 14971, cGMP, CLIA, and QSIT
- Proficient in utilizing quality tools/methodologies including Investigation and Root Cause Analysis, CAPA, Risk Analysis, Statistical Analysis, dFMEA, pFMEA, pareto chart, Ishikawa, flowchart, 5 whys, histogram, 8D, etc.
- Experience in medical device design & development, V&V activities, risk management, product transfer, DHF processes
- Proficient in utilizing product life cycle management systems such as PLM/electronic QMS (e.g., Arena, MasterControl)
- Skilled in drafting procedures, work instructions, reports, and business correspondence with meticulous attention to detail and exceptional accuracy in documentation
- Strong written and verbal communication skills, with proficiency in articulating information clearly and effectively addressing inquiries from management, peers, suppliers, government agencies, and customers
- Capable of problem identification, data gathering, fact establishment, and drawing valid conclusions. Proficient in interpreting a wide range of technical instructions presented in mathematical or diagrammatical forms, and adept at handling various abstract and concrete variables.
- Experience with conducting audits
- Experience with delivering training material to groups
- Highly independent and self-motivated and integrates well in multi-disciplinary teams
- Versatility in navigating a dynamic, fast-paced, small company setting
(Preferred)
- ASQ Certification (e.g., CQE or CQA) or equivalent (e.g., Certified Six Sigma Black Belt)
Essential Physical/Environmental Demands:
- Extended periods of sitting and computer use.
- Ability to operate standard office equipment, such as computers, printers, and phones.
- Occasional lifting of light office supplies and materials.
- Working in a climate-controlled office environment.
- Following ergonomic best practices to prevent strain or injury.
- Visual acuity, color perception, and depth perception for tasks such as reading documents and navigating computer screens.
Our EEO Policy
Seek Labs is dedicated to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, national origin, age, disability, genetic information, sexual orientation, gender identity, or any other characteristic protected by law. We prohibit discrimination, harassment, and retaliation in all aspects of employment, and we strive to foster a diverse and inclusive workplace where everyone is treated with respect.
*Must be authorized to work in the United States. No immigration-related sponsorships are available.
Schedule: 9/80 work schedule with every other Friday off
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Paid time off
- Parental leave
Ability to Relocate:
- Salt Lake City, UT 84103: Relocate before starting work (Required)
Work Location: In person