Quality Assurance Analyst II

Breathe Life Into Your Career

Respironics, a worldwide leader at anticipating needs and providing valued solutions to the sleep and respiratory markets. The company's focus is on home care, hospital, respiratory drug delivery and international markets providing programs that manage sleep disordered breathing, chronic obstructive pulmonary disease, asthma, infant care, congestive heart failure and restrictive lung disorders. Globally positioned has manufacturing facilities in several domestic and international markets.

We have an immediate opportunity in our Kennesaw, GA territory for:

Quality Assurance Analyst II

Responsibilities:
Responsible for complaint processing in compliance with applicable US, Canadian and International Regulations.
Secondary responsibilities include complaint trending, auditing and training.
Complete review and closure of complaints in a timely manner.
Process MDR’s as required. Contact customers or external agencies when more information is required.
Train others in the complaint handling process.
Provide metrics on aging of complaints and trending reports on product performance.
Participate with internal and external audits. Conduct internal audits.
Provide training on Quality System and Career Path elements.
Develop or modify Quality System documents.
Complete complaints in a timely manner and not let a significant back log of complaints develop.
Embrace methods to improve the throughput of complaint review and closure utilizing current automated methods as well as devising innovative methods to enhance productivity.
REQUIREMENTS
Requirements:
Bachelors Degree or equivalent with two years of work experience or an Associates Degree or equivalent with 6 years experience.
Experience in an area of specialization relating to Quality such as quality systems auditing, complaint handling and Medical Device Reporting. Proficient with Federal codes of Regulations 21 CFR, Part 801, 803 and 806.
Familiarity with FDA Quality System Requirements.
Aggressively learn and apply the new skills/knowledge required to be successful within new, changing or uncertain conditions.
Able to make sound decisions with regard to complaints and MDR reporting.
Realistic determination of time to complete task; promptness and punctuality in meeting obligations.

At Respironics Inc., our products improve the lives of patients with a variety of respiratory needs in the hospital, homecare, critical care and neonatal environments. To learn more about our organization, our products and our culture … please apply online and reference job number: 413BR.

Your interest in our company is appreciated however, only candidates considered for interview selection will be notified. AA/EOE.

www.respironics.com