Post Market Quality Specialist

Oliver Tolas Healthcare Packaging • Doylestown, PA

1d

About The Position

The Post Market Quality Specialist manages the internal Corrective and Preventive Action (CAPA) process and administers the customer complaint process in compliance with written procedures and regulatory requirements. The role leads or supports investigations, problem solving, root cause analysis, and process improvement activities, and manages quality records from initiation through closure. The specialist also supports audits and provides backup support for the Post Market Quality Supervisor.

Requirements

• Two years of experience in a quality-related position, preferably in a regulated industry such as food, medical devices, or pharmaceuticals.
• Strong analytical skills, including the ability to apply fractions, percentages, and proportions to practical situations.
• Solid verbal and written communication skills.
• Strong organizational skills and the ability to manage time and multitask effectively.
• Ability to write reports, business correspondence, and procedures.
• Software skills including MS Office and SAP.
• Ability to read, analyze, and interpret SOPs and regulatory standards.
• Ability to present information effectively and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to work evenings and/or weekends as needed.

Nice To Haves

• Strong knowledge of ISO 13485:2003.

Responsibilities

• Manage the internal CAPA process and administer customer complaints in a timely and organized manner.
• Obtain background information on quality issues, production data or samples for investigation, and trace identification information.
• Confirm material disposition using specifications and procedures.
• Communicate quality issue details to a team to determine follow-up activities and distribute assignments to investigators.
• Evaluate and approve completed investigations and review evidence of actions and documentation before closing records.
• Manage quality records from initiation through closure and collaborate with supporting team members to complete activities on time.
• Support problem-solving activities, root cause analysis, and documentation of these activities.
• Support resolution of quality issues, including revising SOPs, implementing process improvements, or sharing findings with relevant teams.
• Perform effectiveness verification after CAPA closure.
• Trend CAPA data using Quality System Reports, charts, and other quality tools as needed.
• Communicate with customers in writing or verbally, including through emails, conference calls, or investigation letters as needed.
• Participate in customer and ISO registrar quality system audits and support resolution of resulting action items.
• Participate on an internal audit team performing multiple audits each year.
• Provide backup support for the Post Market Quality Supervisor.
• Perform additional tasks as needed by the Post Market Quality Supervisor.

What This Job Offers

• Job Type: Full-time
• Education Level: No Education Listed