QA Lead - Medical Devices & Regulatory Compliance

Summary Coordinate the quality assurance systems in accordance with all applicable regulations. Provide leadership and support for customer focused quality and quality system improvement initiatives by performing the following duties personally or through responsible process owners/supervisors/managers. Essential Duties And Responsibilities Duties include, but not limited to the following. Other duties may be assigned. Coordinate quality assurance processes (NCR, Corrective and Preventative Action, Complaint Handling, Product Safety, Change Control, validation programs, Supplier Qualification and Monitoring, Calibration Program, Internal Audit Program, etc.) in compliance with Medical Device industry requirements (ISO 13485, FDA CFR Title 21 Part 820, etc.). Coordinate/assist during various quality system audits: Internal Audits and External (Customer/Third Party) audits for Supplier Qualification and for Quality System certifications. Assess improvement initiatives resulting from all quality audits. Perform QA Final Release activities for all stages of production (incoming, in-process, and finished goods). Interprets specifications, drawings and requirements. Manage area inventories using Purchase Requisitions and Material Transfers. Works with cross functional team members to ensure compliance with FDA/cGMP, ISO and other regulatory requirements. Perform training to support team and foster team environment. Coach and guide employees to support departmental priorities in a positive way. Job Description Job Title: Quality Assurance Technician Summary Coordinate the quality assurance systems in accordance with all applicable regulations. Provide leadership and support for customer focused quality and quality system improvement initiatives by performing the following duties personally or through responsible process owners/supervisors/managers. Essential Duties And Responsibilities Duties include, but not limited to the following. Other duties may be assigned. Coordinate quality assurance processes (NCR, Corrective and Preventative Action, Complaint Handling, Product Safety, Change Control, validation programs, Supplier Qualification and Monitoring, Calibration Program, Internal Audit Program, etc.) in compliance with Medical Device industry requirements (ISO 13485, FDA CFR Title 21 Part 820, etc.). Coordinate/assist during various quality system audits: Internal Audits and External (Customer/Third Party) audits for Supplier Qualification and for Quality System certifications. Assess improvement initiatives resulting from all quality audits. Perform QA Final Release activities for all stages of production (incoming, in-process, and finished goods). Interprets specifications, drawings and requirements. Manage area inventories using Purchase Requisitions and Material Transfers. Works with cross functional team members to ensure compliance with FDA/cGMP, ISO and other regulatory requirements. Perform training to support team and foster team environment. Coach and guide employees to support departmental priorities in a positive way. Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education And/or Experience Bachelors degrees (BA) from four-year college or university or one to two years related experience and/or training; or equivalent combination of education and experience. Language Skills Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations. Ability to write reports, business correspondence and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public. Mathematical Skills Ability to work with mathematical concepts such as probability and statistical inference and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations. Reasoning Ability Ability to define problems, collect data, establish facts and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Other Skills And Abilities Working knowledge of cGMP (QSR), ISO 13485 and Medical Device Directives. Knowledge of Microsoft Office computer programs and previous technical writing experience with clear written and verbal communication skills. Basic knowledge of quality tools (flow diagramming, histograms, root cause analysis and pareto charts) is desirable. Powered by JazzHR #J-18808-Ljbffr Bentec Medical OpCo LLC