Sr. QMS Specialist - Hybrid

Job Description:Under the direction of the Senior QA Manager, this position is responsible for ensuring that core functions of Quality Assurance are consistently in compliance with regulatory requirements and corporate standards. This involves assuring quality standards (FDA, ISO, CMDCAS, MDD, MDR, MDSAP and Canadian Medical Device requirements) are with respect to such processes as CAPA and Internal Auditing.Job Requirements:ESSENTIAL DUTIES AND RESPONSIBILITIESEnsures FDA QSR (GMP), FDA OTC, ISO 13485, MDD, CMDCAS, MDR, MDSAP and Canadian Medical Device and other regulatory and/or national and international standards as applicable are continuously met.Maintain quality systems in compliance with all applicable regulatory standards as above and other relevant requirements throughout the facility.Responsible for the evaluation and submission of Medical Device Reporting to FDA and all competent authorities related to Adverse Events, and Recalls.Function as liaison with Ormco Regulatory Affairs as it relates to new product, MDR/vigilance reporting, product licensing/registrations and other regulatory or compliance issues.Responsible for the Corrective and Preventive Action Process including managing the presentations for the CAPA Review Board (CRB).Identify and oversee Corrective and Preventive Action teams in response to concerns identified through complaints, nonconforming materials or other various concerned activities.Prepare such reports, trend analyses, memoranda and other communications for and on behalf of management which may be called for from time-to-time.Perform such tasks as may be required by management from time-to-time.QUALIFICATIONSTo 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.Knowledge of FDA Medical Device RegulationsKnowledge of FDA process validation guidelinesKnowledge of Current Good Manufacturing PracticesKnowledge of ISO 13485 quality programs & Quality System GuidelinesKnowledge of Quality Assurance/Quality Management SystemsAbilities and skills in management & organizationExcellent verbal and written communication skillsAbility to learn and utilize computer in standard business applications including electronic document control, word processing, spreadsheets and databases.Must be knowledgeable in the proper handling of chemicals and waste, both hazardous and nonhazardous, as defined by FDA, OSHA, EPA and DOT.EDUCATION and EXPERIENCEBachelor Degree or equivalent in Science Discipline or Quality Management3-5 years experience working with an FDA (QSR) and ISO Quality SystemPHYSICAL DEMANDS:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is frequently required to sit. The employee is occasionally required to stand and walk. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this Job, the employee is regularly required to sit. The employee is frequently required to walk. The employee is occasionally required to stand. The employee must occasionally lift and/or move up to 10 pounds.Target Market Salary Range:

$80,000 - $120,000Operating Company:

OrmcoOrmco is a global leader and innovator of high-quality orthodontic products and solutions, including brackets and wires. For more than 60 years, our team has partnered with the orthodontic community to help create over 20 million smiles in more than 140 countries. We build trusted relationships. Each one is rooted in respect and understanding. We take that approach when we help orthodontists achieve their clinical and practice management objectives. We take the same approach when we help our team bring their personal best to work each day, ready to make a difference and reach their full potential.Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

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