Be an early applicantLess than 25 applicants
Kerecis · 2 days ago
Quality Assurance Specialist
Minneapolis, MN
Full-time
Onsite
Senior Level
5+ years exp
Wonder how qualified you are to the job?
Maximize your interview chancesHealth CareManufacturing
Insider Connection @Kerecis
Responsibilities
Attains and maintains proficiency in the Company Critical Quality Requirements
Assists in the development, maintenance, and implementation of processes and procedures in accordance with regulatory requirements
Monitors, maintains, and assists with standards for validation, sterilization, risk management, and design activities
Assists with product return procedures and associated training
Assists with the resolution and documentation associated with customer complaints
Conducts local vendor audits
Participates and leads teams in Quality decisions and practices
Other tasks and responsibilities as assigned
Qualification
Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.
Required
Ability to work within the team as an individual contributor in a fast-paced, changing environment
Advanced computer skills including statistical/data analysis and report writing
Detailed knowledge of FDA, cGMP ISO 13485, and ISO 14971
Works with cross-functional teams to complete assigned tasks
Skill and ability to think analytically by solving problems to make decisions
Strong communication skills (oral and written), with excellent presentation technique
Self-motivated problem-solver / trouble-shooter with a strong bias for action
Demonstrated ability to lead technically driven projects
Ability to interact with multidisciplinary colleagues in a team environment
Ability to motivate and guide others to meet objectives and drive actions to closure
Innovative thinker, creative, willing to challenge established thinking
Flexibility and adaptability in response to rapidly changing priorities
Ability to collaborate in a cross-functional and external environment
Comfortable coordinating with vendors by phone and email
Strong work ethic to deliver high-quality products on time and within budget
Proficient organizational, record-keeping skills
Proficiency in Microsoft Office suite
BS in Engineering or Technical Field, advanced degree preferred
5+ years of medical device experience
Preferred
ASQ CQE or other certifications preferred
Company
Kerecis
Kerecis is a commercial stage company pioneering the use of fish skin and fatty acids in cellular-therapy and regenerative-medicine
501-1,000 employees
Funding
Current Stage
Late StageTotal Funding
$123.61MKey Investors
KIRKBISilicon Valley BankTechnology Development Fund
2023-07-07Acquired· by Coloplast ($1.3B)
2022-07-21Series D· $60M
2022-07-21Debt Financing· $15M
Leadership Team
Gudmundur Fertram Sigurjonsson
Founder, President & CEO
Gunnar Jóhannsson
SVP of Research & Development
Recent News
2024-06-04
Medical Device Network
2024-06-04
2024-06-04
Company data provided by crunchbase
