Design Assurance Quality Engineer
Design Assurance Quality Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Description
Provide Quality Engineering support for Product Development Projects throughout all phases of Design Controls (Concept to Launch) with additional responsibility for post-market surveillance activities. This is a collaborative position working closely with R&D Manufacturing Sales & Marketing and others to ensure compliance with AVIs QMS and FDA QSR requirements with a particular focus on Design Controls.
Duties & Responsibilities
Fulfill a Design Assurance (DA) role on Product Development projects
Lead cross-functional teams to implement risk assessment (FMEAs) and risk management processes (RMP / RMR / RMF)
Support development implementation and maintenance of Design Verification & Validation (V&V) methodologies and best practices to impact product quality and launch timeliness
Interface with manufacturing NPI Engineering Research and Development and other Quality team members to ensure effective design transfer to manufacturing
Qualifications
BS in related technical field preferably Engineering
3-5 years of design assurance experience in the Life Science or Medical Device Industries
Working knowledge of 21 CFR 820 and ISO 14971:2019 are a must
Working knowledge of data analysis methods including basic statistics preferably using Minitab or other similar data analysis software
Teamwork flexibility and adaptability to change
Critical reasoning and excellent data presentation skills
Excellent written and verbal communication and skills
Self-initiator with strong organization skills
Ability to lead through influence
Conditions of Employment:
Candidates will be required to show proof that they are fully vaccinated against COVID-19 prior to commencing employment. For purposes of this requirement fully vaccinated shall have the then-current meaning ascribed by the US Center for Disease Control and Prevention (CDC). Exemptions from this requirement as a reasonable accommodation will be considered on a case-by-case basis in accordance with applicable law.
Access Vascular Inc is a proud Equal Opportunity/Affirmative Action Employer. Allqualified applicants will receive consideration for employment without regard torace color religion sex sexual orientation gender identity nationalorigin age protected veteran status or disability status.
About Access Vascular
Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy: infection thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and have demonstrated 6X fewer complications. .
Employment Type
Full Time
