Quality Assurance Engineer

MicroAire Surgical Instruments, LLC Located in: Charlottesville,  Virginia
(Private and Secure - Guaranteed!)

MicroAire Surgical Instruments, LLC Biotechnology Jobs Pharmaceutical Careers
 

JOB DESCRIPTION

Come join the MicroAire Team! We are seeking a highly motivated Quality Assurance Engineer for the Quality activities associated with the continued support of current products as well as new medical device products.  Joining a team of expert Quality Assurance Engineers, this role partners with cross functional teams to continuously improve the Quality Management System (QMS) and its execution; applies risk-based criteria to prioritize actions related to Corrective Action/Preventative Action (CAPA) and post-marketing quality systems.  Additionally, this role conducts quality engineering activities for the development of new medical devices, performing activities such as design verification, design validation, risk analysis, risk management reports, equipment installation qualification, process operational qualification, process performance qualification, packaging validation, sterilization validation and supplier quality.  As a New Product Development team member, helps to generate the specifications, testing requirements, and documentation associated with development/domestic (510(k) submissions.  A Bachelor’s degree in related field (engineering degree preferred), and two to three years Quality Assurance Engineer experience in the medical device industry are required.  Understanding of medical device Quality Assurance and domestic Regulatory Affairs/ 510(k) submissions and 21 CFR 820.30, Design Controls, and 820.75, Process Validation desired.

MicroAire is a manufacturer and distributor of powered and non-powered general surgical instruments, sterile-packaged disposable orthopaedic accessories, Endoscopic Carpal Tunnel Release (ECTR) surgical instruments, power-assisted liposuction (PAL) surgical instruments, and bioabsorbable implants (Endotine).  MicroAire is a team dedicated to enhancing quality of life: For Surgery…For Life

MicroAire is located in beautiful Charlottesville VA. home of University of Virginia and two large hospitals.  Charlottesville is consistently ranked as one of the best places to live in America.  We offer an excellent benefits package & compensation commensurate with experience. For more information and to apply for this position visit our website at www.microaire.com (EEO)

CRITICAL REQUIREMENTS

  • A Bachelor’s degree in related field (engineering degree preferred), and two to three years Quality Assurance Engineer experience in the medical device industry are required.  Understanding of medical device Quality Assurance and domestic Regulatory Affairs/ 510(k) submissions and 21 CFR 820.30, Design Controls, and 820.75, Process Validation desired.

COMPANY INFORMATION

MicroAire’s cost-containment pricing and quality craftsmanship ranks MicroAire as a top manufacturer in the medical device industry for over three decades. MicroAire cherishes its reputation as a company whose performance is matched by its commitment to integrity and to continuously improving surgeon and patient outcomes.

JOB INFORMATION

Seniority Level:
Experienced - Not Management
Function:
  Quality
Preferred Industry Background:
  Medical Device
Managing a team of:
N/A
Required Travel:
Very Little - 1 week per month

Base Salary:
Confidential
Bonus:
Benefits:
We offer an excellent benefits package & compensation commensurate with experience.
Other Compensation:
Education Required:
Undergraduate
Therapeutic Experience:
Orthopedics
Class of Device:
Class 2