If you have a strong Quality Engineering background in the Quality and Regulatory space, we encourage you to apply for the Quality Engineer position at Glytec. We are a fast-growing healthcare solution company conveniently located in Waltham off of Route 128.
The Quality Engineer is a critical member of Glytec’s Quality and Regulatory team and works closely with the Sr. Director of Quality and Regulatory Compliance in the Glytec’s Quality Management System as well of product design through post-market activities. Our FDA-cleared titration software and proprietary algorithms power the only solution capable of delivering personalized insulin treatment recommendations across the continuum of care. This individual will play a key part of the team during a time of growth and optimization – with an opportunity to work with departments across the organization as we deploy our solution at hospitals and health systems nationwide.
Essential Job Functions:
- Assist in maintaining the company’s Quality Management System (QMS), that complies with ISO 13485 and 21 CFR Part 820.
- Develop, administer and maintain quality system policies, procedures and activities required to ensure that the company’s processes, records and products are in compliance with applicable requirements.
- Promote quality achievement and performance throughout the organization, including identifying and setting quality assurance and regulatory compliance objectives, and ensuring that targets are achieved.
- Continuously review and improve QA processes and procedures through routine tracking and trending of quality data.
- Assist with all FDA inspections, ISO Audits and Internal Audits as well as defining responses and implementing corrective and preventive actions
- Stay up to date with the latest quality system changes and requirements for FDA and other applicable international agencies / organizations.
- Provide guidance for all applicable regulations and standards (FDA, ISO) ensuring the proper policies and procedures are in place to obtain necessary regulatory approvals and maintain regulatory compliance.
- Monitor regulatory changes and developments and identify risks to Glytec’s products and processes.
- Assist with regulatory submissions to help ensure accurate and conduct timely determinations of significance, where appropriate.
- Educate employees on regulatory requirements to assure compliance with requirements.
- Ensure all marketing, sales, and other materials and practices are in conformance with regulatory requirements including conformance to FDA cleared labeling.
- Review and closure of complaints, MDRs, and CAPAs
- Collaboration skills
- Verbal and written communication proficiency.
- Team participation and leadership skills.
- Problem Solving/Analysis skills.
- Time Management
- Comfortable speaking to and training groups of people.
- Performing and documenting regulatory compliance audits
- S./B.A. degree in science or Engineering is preferred, or equivalent work-related skill, knowledge, or experience
- FDA medical device regulatory requirements including 21 CFR Part 820, Quality System Regulation, ISO 13485, and international regulatory compliance knowledge is a plus.
- Previous experience in medical device quality and regulatory affairs a plus.
- Diabetes and software experience and/or knowledge are a plus.
- Strong interpersonal, communication, organizational, and presentation skills. Good computer skills in Microsoft Office; Project, Word, Excel, and Good business ethics and common-sense skills. Ability to learn and adapt to different working environments.
- Travel is required.
- Nights and weekends may be required to achieve the goals of the department and the company.
- Independent remote work combined with video conferencing.
The above statements are intended to describe the general nature and level of work being performed by personnel assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
All offers of employment are contingent on the results of a background check and drug test.