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Responsible for managing the Internal CAPA process and administering the customer complaint process in compliance with written procedures and Regulatory requirements , as well as l eading or supporting investigation and process improvement activities.
Primary Responsibilities / Essential Functions
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 i nvestigators .
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.
Lead problem-solving activities, root cause analysis, and/ or documentation of these activities using industry standard root cause investigation tools .
Support activities to resolve quality issues, such as revising SOPs , implementing process improvements or sharing findings with the team s involved .
Perform effectiveness verification after CAPA closure .
Trend CAPA data using Q uality System Reports, charts, and other quality tools as needed.
Lead proactive projects to improve internal processes.
Independently i nterface with the customer regarding critical complaints, through written or verbal communication, including emails, conference calls or investigation letters .
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 .
Basic Qualifications
Education
Bachelor’s Degree , certification or equivalent in the Medical Packaging Industr y or Quality Assurance field.
Five years’ experience in a quality -related position , preferably in a regulated industry such as food, medical device or pharmaceuticals.
Experience
Strong Knowledge of GMP and ISO requirements.
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 procedure s .
S oftware 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 .
Preferred Qualifications
Strong knowledge of ISO 13485:2003 .
Special Requirements
Ability to work evenings and/or weekends as needed.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Administrative
Industries
Packaging and Containers Manufacturing
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