Job Description

The Quality Assurance Specialist is responsible for new product development programs and the overall quality compliance systems. This position ensures that systems are within the guidelines set forth by FDA and ISO. Responsible for managing the QA projects which include: performing internal ad supplier audits associated to new product introductions, inspection and testing requirements, validations, production compliance and environmental and microbial control programs.



Candidate will have experience maintaining a complaint handling system, which includes FDA MDRs and EU Vigilance reporting, Post-Market Surveillance, CAPAs, Agency Audit responses and routine Agency reporting.

 

Primary Responsibilities (include, but are not limited to):

• Support with PPQA activities, validations, and statistical analysis of new products and processes. Is responsible for the CE Mark approval process for all products, which includes MDD Checklist requirements, compilation of Technical Files and Product Dossiers.


• Coordinates projects with the new product development teams, QC Inspection, QA Manager, Document Control.


• Ensures all inspection and quality plans are statistically sound and can ensure quality levels that exceed requirements. Prepares sampling plan rational when applicable.


• Ensure all manufactured products are conforming to FDA Quality System and ISO requirements.


• Oversee all product release activities, including submission of EU and FDA registrations.


• Experience with FDA MDR


• Familiarity with CAPA

Auditing/Corrective Action/Recalls

• Assists with internal ISO and QS Audits and is responsible for annual facility and product registrations


• Assists with supplier audits


• Is able to act as lead in all product recall or market correction campaigns

Knowledge, Skills & Requirements

• Bachelor’s degree in a technical discipline or higher, preferably Mechanical Engineering


• Ability to interpret blueprints, and previous training in mechanical test methods, statistical analysis, and/or inspection methods a must


• Excellent written and oral communications skills. Well-developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing. Experience working in a global environment is a plus


• Demonstrated problem solving and decision-making skills including hands-on working knowledge of statistics and familiarity with sampling plans including SPC, SQC, DOE, pass/fail strategies, Six Sigma/DAIC and analysis of process variations is required


• Minimum of 3 years’ experience preferably in the medical device industry