Oliver Healthcare Packaging · 6 hours ago
Post Market Quality Coordinator
Feasterville-Trevose, PA
Full-time
Onsite
Entry Level
2+ years expOliver Healthcare Packaging is focused on providing high-quality packaging solutions in the healthcare sector. They are seeking a Post Market Quality Coordinator responsible for managing the Internal CAPA process and customer complaint process while ensuring compliance with regulatory requirements and leading process improvement activities.
Health CareManufacturingMedicalPackaging Services
Responsibilities
Responsible for managing the Internal CAPA process and administering the customer complaint process in a timely and organized manner:
Obtain background information on the quality issue
Obtain production data information and/or corresponding samples for investigative purposes
Obtain trace identification information
Confirm material disposition using specifications and procedures
Communicate details of the quality issue to a team to determine required follow up activities
Distribute assigned activities to investigators
Evaluate and approve completed investigations
Evaluate evidence of actions and documentation before closing record
Manage quality records from initiation through closure
Communicate and collaborate with supporting team members to complete activities in a timely manner
Support problem solving activities, root cause analysis, and/ or documentation of these activities
Support activities to resolve quality issues, such as revising SOPs , implementing process improvements or sharing findings with the teams involved
Perform effectiveness verification after CAPA closure
Trend CAPA data using Quality System Reports, charts, and other quality tools as needed
Interface with the customer through written or verbal communication, including emails, conference calls or investigation letters , as needed
Participate in Customer and ISO registrar quality system audits . Provide support for resolving resulting action items
Participate on an Internal Audit Team performing multiple audits each year
Provide back up support for the CAPA Team Leader
Perform additional tasks as needed by the CAPA Team Leader
Qualification
Required
Two years' experience in a quality-related position, preferably in a regulated industry such as food, medical device or pharmaceuticals
Strong analytical skills, including ability to apply concepts such as fractions, percentages and proportions to practical situations
Solid verbal and written communication skills
Strong organizational skills and the ability to effectively manage time and multitask
Ability to write reports, business correspondence, and procedures
Software skills including MS Office and SAP
Read, analyze, and interpret SOPs and Regulatory Standards
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
Ability to work evenings and/or weekends as needed
Preferred
Strong knowledge of ISO 13485:2003
Company
Oliver Healthcare Packaging
Oliver Healthcare Packaging is a medical product packaging company.
501-1000 employees
H1B Sponsorship
Oliver Healthcare Packaging has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
Funding
Current Stage
Late StageLeadership Team
Michael Benevento
Chief Executive Officer
Douglas Kramer
Chief Financial Officer
Recent News
Company data provided by crunchbase