Sr. Quality Assurance Specialist
Company: KARL STORZ ENDOSCOPY
Location: Charlton
Posted on: March 18, 2023
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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
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