[Hiring] NC/CAPA Specialist @Convatec

Role Description

Supports global oversight of the Non-Conformance (NC) and Corrective Action/Preventive Action (CAPA) system.

• Ensures compliance to FDA 21 CFR Part 820, ISO 13485:2016, Medical Device Single Audit Program, and other applicable global Quality System Regulations.
• Assists in maintaining the global NC/CAPA process including monitoring process performance and implementing continuous process improvement.

Responsibilities

• Demonstrate methodical problem-solving skills in a fast-paced continuous improvement culture.
• Use and promote the benefits of structured and standardized Lean / Six Sigma / KT methodology for process improvement and development.
• Work with internal team members cross-functionally and external partners around the globe while maintaining professionalism at all times.
• Supports internal and external audits and inspections for NC/CAPA records and processes and other roles as needed.

Nonconformance and CAPA Process

• Provides continuous and rigorous assessment of global NC/CAPA activities and documentation to assure compliance with NC/CAPA processes, FDA regulations, ISO 13485, and Medical Device Requirements through the review of NC/CAPA records.
• Ensures that NC/CAPA records are routed, reviewed, approved and implemented in a timely manner per established procedures.
• Provides guidance, support and mentors NC/CAPA Owners, NC/CAPA Leads and CAPA Board Members regarding the NC/CAPA process, NC/CAPA best practices, NC/CAPA record content, and NC/CAPA software tools.
• Support NC/CAPA Leads, CAPA Board Members and Executive Management with metrics and reporting on critical aspects regarding the status of the NC/CAPA process.
• Works cross-functionally with a sense of urgency to ensure timely, compliant and effective NC/CAPA records.
• Hosts and participates in Corporate NC/CAPA Escalation & Board meetings.
• Supports the development and implementation of Quality System NC/CAPA procedures, NC/CAPA software, and NC/CAPA training programs.
• Identify and assist with the implementation of updates to the NC/CAPA TrackWise module; including participating in validation efforts e.g., user acceptance testing.

Skills & Experience

• Comprehensive understanding in mechanism and key components in Quality Management System.
• Knowledge of regulations and standards in the quality management system for Medical Devices, e.g. ISO 13485.
• Effective at problem solving and data analysis (trending) while maintaining attention to detail.
• Willingness to adhere to all principles of confidentiality.
• Comfortable working in a highly regulated, fast-paced environment.
• Effective and proactive communication, particularly in a remote-working situation.

Qualifications and Education

• Bachelor’s Degree in Science, Engineering, or related discipline.
• Minimum 5 years supporting a global Non-Conformance/CAPA process in the medical device or healthcare industry.
• Intermediate to Expert skill level utilizing TrackWise.
• Knowledge of and the ability to translate and apply the requirements of ISO 13485:2016, 21 CFR Part 820, and the Medical Device Single Audit Program (MDSAP).
• Ability to deal with difficult situations with tact and professionalism.
• Ability to communicate effectively in both oral and written communications, and work with employees at all levels of the organization.
• Demonstrate problem solving and troubleshooting skills.
• Ability to work without close supervision and produce quality work.
• Strong computer skills: MS Office (Outlook, PowerPoint, Word, and Excel), Microsoft Teams, and Adobe Acrobat Pro.

Principal Contacts & Purpose of Contact

• Internal – Global Site NC/CAPA Leads, Site Quality Leads, Compliance, Information Management and Executive Management.
• External – External Auditors and Inspectors, Regulatory Agencies, and Notified Bodies.

Travel Requirements

• 5-10% domestic/international travel may be required, this may include overseas travel. Most trips will include overnight travel.

Languages

• Speaking: Yes English
• Writing/Reading: Yes English
• Additional languages such as Spanish

Working Conditions

• This is a remote position, but office presence will be required or allowed for certain meetings, events, or to meet certain business needs.

Equal Opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.