QA Technician - Inspection/Validation

the Client•Burlington, MA

1d•Onsite

About The Position

This position is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, or system/services support.

Requirements

Minimum 2 years (2–4 years') experience.
Previous experience in assisting with validations & qualifications, Gage R&R, calibration, test methods, and NCMR dispositioning.
Knowledge of Quality Systems, FDA regulations, ISO 13485, and applicable worldwide regulatory requirements.
Experience with optical measurement equipment, hand tools, gages, pressure and force gage testing, and fixture design.
Training in blueprint reading and experience with sampling techniques.
Good communication and computer skills, including data analysis and report writing skills.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes, and meets deadlines in a timely manner.
Strong organizational and follow-up skills, as well as attention to detail.

Nice To Haves

Prior medical device experience preferred.
Experience working in a broader enterprise/cross-division business unit model preferred.
ASQ CQT certification or equivalent preferred.

Responsibilities

Perform first article incoming inspection of purchased components and inspection of production operations, including documenting inspection and audit results.
Perform final product inspections against specification and procedural requirements.
Document nonconformances as appropriate.
Monitor and/or perform calibration and maintenance of all test equipment and fixtures.
Initiate related documentation changes.
Perform Process Control & Monitoring of critical-to-quality parameters and specifications.
Collect data, summarize, and document test results.
Assist with or perform Gage R&R studies.
Assist with the selection, installation, and programming of precision measuring equipment.
Create and maintain control plans for products and processes.
Assist in writing, executing, and documenting equipment, product, process, and test method verifications, qualifications, and validations.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintain positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors.