The QA/QC Technician performs various quality testing functions within the quality organization. The QA/QC Technician follows Standard Operating Procedures and detailed schedules and assignments. The QA/QC Technician documents their work per Good Documentation Practices to ensure data integrity and traceability. This position performs a variety of analytical and process functions. The QA/QC Technician follows internal policies and procedures in compliance with current FDA GMP policies/regulations, applicable ISO standards and AMS internal quality standards.
The QA/QC Technician will focus in one or more of the following disciplines:
Performs calibrations on manufacturing, R&D, and laboratory equipment. Maintains standards, supplies and materials. Prepares equipment and assists contract calibration technicians with internal calibrations. Reviews calibration certificates, and assists with Out of Tolerance Investigations. Works with teams to establish calibration methods for new equipment.
Receiving and Inspection
Performs inspection and measurement verification activities on incoming components and raw materials. Coordinates samples for testing at external contract labs and with the component services group. Sets-up and accurately operates testing equipment, Performs “First Article” Inspections and performs mold validations to assure parts are within defined specifications.
The Product Release Technician executes project tasks for the release to finished goods of new products and the processes to control product release. This individual works to improve the current product release systems and performs sterilization chart reading and quality hold with supervision from the Senior Microbiologist.
The Production Floor Quality Technician will execute the review of finished device paperwork and disposition any discrepancies. This person will initiate and close out product on the nonconforming materials process.
All positions are responsible for following applicable AMS policies and procedures as defined by their manager.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Follows SOPs to perform routine and non-routine quality functions such as: raw material, in process and final product sample handling and analysis; chemical, studies, investigations; result documentation, data entry and review; laboratory and equipment use and maintenance; and change control and deviation initiation.
- Recommends changes to existing SOP’s and participates in drafting new SOPs
- Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.
- Exercises judgment within generally defined procedures and policies in selecting methods and techniques to troubleshoot problems and/or formulate solutions.
- Typically receives no instructions on routine work, general instructions on new assignments and non-routine work
- Frequently has cross-departmental interaction based on defined tasks and purposes
- Involved with inter or intra-departmental projects such as procedure updates, CAPA activities, and internal audits
- Looks for issues and takes action to ensure quality standards are met.
- May assist in training new Quality employees on routine procedures and practices
- Performs additional tasks and duties as assigned
- High School diploma required
- Associates Degree preferred
- ASQ Certification preferred
- 5-10 years minimum experience with a high school diploma or 3-5 years minimum experience with an Associates degree or equivalent experience
- Previous experience in a medical device environment desirable
- Knowledge/experience with cGMPs, ISO, ASTM, and applicable standards
- Demonstrates a basic understanding of the overall quality system.
- Able to follow written instructions and procedures
- Clear and precise documentation/writing skills
- Demonstrates attention to detail
- Strong organization skills
- Consistently demonstrates communication, teamwork and collaboration skills
- Ability to multitask and shift priorities as required
- May require lifting up to 25lbs
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.