Sr. Quality Assurance Specialist

Company: KARL STORZ ENDOSCOPY
Location: Charlton
Posted on: March 18, 2023

Job Description:

Company OverviewKARL STORZ Endovision (KSE) develops, manufactures and services fiberoptic and digital video endoscopes.KSE services all flexible endoscopes distributed in North America, as well as, many globally distributed endoscopes.The facility also manufactures and services a variety of electromechanical devices -light sources, insufflators and other electronic accessories that provides high quality medical care.To become part of this dynamic team, we invite you to learn more about our opportunities.Role OverviewIf you are detailed oriented person looking for opportunity to grow, KARL STORZ Endovision, Inc. has an exciting opportunity for you. As the Quality Assurance Specialist, the ideal candidate will be the go to person to for compliance with FDA/GMP and ISO Regulations and Quality Systems within the organization.This role will afford the opportunity for the successful individual to showcase and develop a compliance and regulatory skill set.Key ResponsibilitiesAll employees are expected to be knowledgeable about and follow the Company's Equal Employment and Affirmative Action Policies, including policies on the rights of individuals with disabilities and harassment.Ensures quality activities are carried out according to regulatory and quality requirements.Reviews CAPA investigation reports to assess the appropriateness of the identified corrective and preventive action(s) and CAPA effectiveness.Report metrics for CAPA, internal audits, and other projects or systems, as assigned, to identify trends and implement improvements.Provides support in the preparation for, conduct of, and follow-up activities associated with regulatory inspections, internal audits, and client audits.Support internal and external audits of products and processes.Provide training and direction to manufacturing and QA personnel.Experience with delivering presentations, facilitation and teaching to diverse audiences.Prepare and process Engineering Changes.Functions as department lead on occasion of Manager's absence.Generate targeted metrics for Management Review.Key RequirementsBachelor's Degree or equivalent experience.3-5 years' experience, or equivalent education, in manufacturing and quality assurance of medical devices.In-depth knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and other applicable quality systems requirements.Strong skills with or the ability to learn software applications including Microsoft Word/ Excel/SharePoint/Teams/Visio, Adobe Acrobat DC and SAP.Ability to create, maintain, and improve quality system processes.Experience with quality management system processes such as CAPA, management review and internal auditing is a plus.Ability to communicate effectively with personnel at all levels both verbally and in writing.Excellent oral and written communication skills with strong technical writing experience.Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders.A self-starter able to function independently with minimum direction and to act on behalf of the Quality Manager in his/her absence.#LI-PND1

Keywords: KARL STORZ ENDOSCOPY, Worcester , Sr. Quality Assurance Specialist, Other , Charlton, Massachusetts