Quality Assurance Specialist
Our client is part of a team of life science companies who are developing products that are paving the way in the fight to save lives.
If you are looking for an opportunity to contribute your skills and knowledge and be part of a team, they have an opportunity for a Quality Assurance Specialist.
In this role you will
- Serves as a quality system resource/ expert for colleagues
- May lead small projects with manageable risks and resource requirements
- Assist in solving complex problems affecting the quality system
- Responsible for supporting the maintenance of the site quality system: maintain quality system documentation including record management, document control of QMS and DHF documents, and periodic review and update of SOP/WI
- Non-conformance and CAPA co-ordination
- Various documentations - training record management, supplier management, internal audits
- Support quality metric data collection and reporting
- Establish and maintain strong relationships with internal teams
- Maintain working knowledge of relevant regulations and quality system requirements that affect the business
Salary: $DOE/ hr (contract)
Schedule: FT, 40 hrs, Mon-Fri, 8:00am - 5:00pm (2 days Hybrid and 3 days on-site)
Location: Danvers, MA
Benefits: Health Insurance available – Medical / Dental/ Vision
- Bachelor’s degree - science, engineering, medical, or technical field and previous experience w/ responsibility in medical device QA topics – Required!
- Previous experience - ISO 13485:2016, IVD Regulations, FDA 21 CFR part 820 and domestic/international Medical Device Regulations – Required!
- Team player - comfortable interacting w/ -BU leaders, QA leaders, R&D leaders, and associates
- Ability to apply practical QA experience and knowledge to one or more area(s) of quality assurance
- Ability to work independently
- Strong communication and writing skills with the ability to use appropriate software tools to develop and edit documents, procedures, reports
- Strong commitment to quality and compliance
- Skills to be successful – organized, detail oriented, high level of initiative, self-motivation, reliable and responsive
- Customer focused with a high level of integrity, transparency and humility
Keywords: quality, quality assurance, manufacturing, FDA, ISO, GMP, quality systems, life science, engineering, medical device, QA, IVD, quality systems
"By applying to this position, you are confirming that you understand the requirements needed for this position, and further confirm that you possess the necessary skills and requirements, as outlined above".