Manage the Non-conformance and CAPA processes and systems for the site. Maintains the process for monitoring key performance and quality metrics for the site. Reviews, analyzes, and reports on quality systems metric results and trends through established forums (i.e. Data review meetings, Quality Review meetings, etc).
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Manages the process for ensuring that CAPA projects are completed in accordance with relevant ISO and regulatory requirements (i.e. ISO 13485, CFR 820.100), Customer requirements, Procedural requirements, Nypro Advance Problem Solving methods, and that documentation is complete and compliant with requirements.
- Manages the Nonconformance process in accordance with relevant ISO and regulatory requirements (i.e. ISO 13485, CFR 820.90), Customer requirements, Procedural requirements, Nypro Advance Problem Solving methods, and that documentation is complete and compliant with requirements.
- Manage monthly, quarterly, and bi-annual quality reviews (Internal and Customer joint reviews) to asses if the QMS continues to meet established regulatory compliance requirements, and assess opportunities for improvement
- Support the quality issue escalation processes (internal and customer) as required.
- Support CAPA and Non-conformance investigations and tasks, to determine root cause, corrections, corrective and preventive actions, and effectiveness monitoring actions (as applicable).
- Provide training, coaching, and consultation services to business partners as it relates to the CAPA and Non-conformance process, system, and overall requirements.
- Support Customer Manufacturing Investigation requests to assist in root cause identification and required corrective actions.
- Support external audits (i.e. FDA, MDSAP), Customer audits, Internal audits as it relates to the CAPA and NC processes.
- Partner with cross-functional leaders on continuous improvement initiatives related to the CAPA and Non-conformance processes.
- Maintain and revise applicable procedures as necessary.
- Support all company safety and quality programs and initiatives.
- May perform other duties and responsibilities as assigned.
MANAGEMENT & SUPERVISORY RESPONSIBILITIES
- Typically reports to Management. Direct supervisor job title(s) typically include: Quality Systems Manager
- Job may be responsible for managing other employees (e.g., hiring/termination and/or pay decisions, performance management).
- QSR, ISO and other regulatory requirements knowledge, required.
- Background in Medical Device Industry, preferred.
- Knowledge of failure investigation and root cause analysis tools required
- Knowledge of statistical analysis tools (SPC, CPK, Pareto, etc) required.
- Knowledge of risk management process and requirements preferred
- Strong communication, influencing, and presentation skills required.
- Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required.
EDUCATION & EXPERIENCE REQUIREMENTS
- BS degree or equivalent
- 4-6 years of experience
- Or an equivalent combination of education, training or experience.
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