QA Specialist

Industry

Health and Safety

Advert ID

USA_459482

Location

Exton

Job Type

Contract

Hours

Full-Time

Salary Range

Based on Experience

No. of Openings

1

Branch Information

East Norriton, PA - (USA) 2868 Dekalb Pike PA East Norriton , PA 19401 Phone : 610-313-1401

Branch Phone Number

610-313-1401

Job Description

Duties



* Oversee and actively participate in the writing, creation, conservation and control of quality system documents and records including but not limited to; Change Controls, Corrective/Preventive Action Requests (CAPA), Customer Complaints, etc.

* Conduct customer complaints and CAPA investigations in a timely manner including action plans and verification of effectiveness.

* Generate and control monthly and quarterly reports on critical quality tracking and trending metrics for Management Reviews.

* Ability to objectively deal and communicate with individuals using appropriate tact and diplomacy to establish and maintain a congenial relationship.

* Good word processing and database skills.

* Detail oriented with excellent time management and organizational skills.

* Must be reliable and capable of working with minimal supervision

* Familiar with aspects and elements of quality systems, i.e. Change Control, Complaints Handling, Measurement and Analysis, CAPA, etc.

* Excellent verbal and written communication skills.

* Computer literate with prior database processing experience.

* Extraordinary organizational skills.

* Extreme attention to detail and accuracy.

* Knowledge of current Food and Drug Administration (FDA) laws, regulations, practices, and guidelines.

* Knowledge of ISO 13485:2016, 93/42 EEC and SOR 98/282



Education/ Experience Requirements

*Bachelor degree, with 3-5 yrs. of work related experience in a regulated design and manufacturing environment

* Prior experience in establishing and processing Change Controls, Corrective/Preventive Actions, and Customer Complaints strongly preferred.

* Practical understanding of FDA Regulations, ISO 13485 Standards and Medical Device Directive is strongly desirable.

* Strong Knowledge of medical device and/or pharmaceutical manufacturing environment