We have been retained by Histosonics, a startup company in the Twin Cities, to recruit a Quality Systems Specialist. The company is developing a sonic beam therapy platform capable of destroying tissue at a subcellular level.
In this role you will be part of a small and growing team where you will focus on quality systems support, processing documentation changes, managing associated training assignments and coordinating equipment calibration and maintenance records in their eQMS (Grand Avenue). If someone is at a Senior level they would also handle CAPA Coordination Support.
Once the company is distributing commercial product, this position may also help with receiving inspection (documentation review, not physical measuring) and complaint coordination activities.
Candidates MUST live in the Twin Cities area as this is a hybrid role and relocation is not being considered.
Skills and Abilities Expectations:
- Strong attention to detail
- Understanding of medical device industry Good Documentation Practices (GDP)
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Multitasks, prioritizes, and meets deadlines in timely manner
Minimum Education/Experience Qualifications:
- Bachelor’s or AA Degree plus 1 year medical device experience, or no degree with 3 years medical device experience
- (Sr. Level) – Bachelor’s or AA Degree plus 3 years of medical device experience, or no degree with 5 years medical device experience
Preferred:
- Experience with electronic Quality Management System (eQMS) software (preferably Grand Avenue Software)
- Experience with Document Control processing
- Experience with Equipment Calibration and Maintenance coordination
- Familiarity with Receiving Inspection documentation
- Familiarity with Complaint Handling processes and records
- (Sr. Level) – Experience with CAPA processes and records