Juno Search Partners · 1 week ago
ISO QA Specialist
Horsham, PA
Full-time
Onsite
Mid Level
3+ years expJuno Search Partners is seeking a hands-on QA Specialist to support Quality Assurance activities in a regulated medical device manufacturing environment. The role focuses on QMS administration, documentation oversight, batch record review, and audit support within a growing QA/QC/QE organization.
ConsultingMarketing
Responsibilities
Review, approve, and document batch records and support product release activities
Administer and maintain QMS documentation in compliance with ISO 13485 and applicable regulations
Serve as Document Control and Training SME, including administration of the electronic QMS (Grand Avenue)
Compile, analyze, and report QMS metrics and quality data
Drive continuous improvement initiatives across quality systems, procedures, and workflows
Implement, review, and facilitate investigations, including CAPAs (typically as a system reviewer rather than CAPA owner)
Assist with and/or lead customer complaint investigations and resolution
Support and manage change controls/ECOs and associated documentation
Lead Material Review Board (MRB) meetings and facilitate material and documentation dispositions
Coordinate, support, and perform internal audits and process audits
Support audit preparation and execution for internal, customer, and external audits
Communicate deficiencies, risks, and compliance issues to QA/RA leadership
Administer and deliver Quality Assurance training to internal teams
Support Quality Control (QC) testing and release activities as needed
Collaborate with Operations, Manufacturing, and other stakeholders to ensure compliant execution
Qualification
Required
Bachelor's degree in a Scientific or Life Science field, or equivalent experience
3–5 years of Quality Assurance experience in a regulated environment
Experience with QMS documentation and Good Document Practices required
Strong technical writing skills with attention to detail and documentation quality
Analytical, systems-oriented problem solver
Comfortable navigating multiple systems and managing competing priorities
Proficient in Microsoft Word, Excel, Outlook, and PowerPoint
Ability to work independently with minimal day-to-day direction
Effective communicator in one-on-one and group settings
Collaborative, personable, and proactive mindset
Preferred
Medical device experience under ISO 13485 strongly preferred
ISO 9001 experience acceptable; pharma-only backgrounds may be less suitable
Prior experience with electronic QMS systems (Grand Avenue or similar) preferred
Company
Juno Search Partners
Juno Search Partners is a boutique search firm.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknown2022-11-17Acquired
Leadership Team
Mikal C Harden
Co-Founder
Recent News
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