- Business Lead who coordinates the efforts of a geographically dispersed team of Quality, Regulatory, and IT form the Post Market Surveillance team.
- Ensures compliance to ISO 13485, 21CFR 820 Quality System Regulations, and other applicable regulations and standards by providing support for interpretation of regulations, performing gap analysis, and leading activities to implement improvements.
- Possesses and applies comprehensive knowledge of Quality, and its application to the field of Post Market Surveillance.
- Maintains requirements and knowledge of the ETQ infrastructure and interfacing tools in order to manage the underlying tool chain for post market surveillance processes.
- Manages complaint lab investigation processes, tools, infrastructure, and personnel to support rapid evaluation of product nonconformance allegations.
- Responsibility for providing regional insight and metrics for the performance of embecta products by region and by country to Regional GMs and their teams.
- Identifies core process problems and applies problem-solving skills in order to resolve issues associated with allegations of product and or process nonconformance. Troubleshoots and resolves complex problems with effective solutions.
- Identify business needs and recommend viable solutions to meet those needs while ensuring regulatory compliance and leading strategic decision making.
- Provide key input and metrics for Quality Management System Reviews.
- Partner with the embecta Regulatory lead, to ensure compliance to global reportable event procedures and standards for diabetes care products.
- Partner with IT in delivering infrastructure that supports process requirements.
- Utilizes risk-based assessment techniques to resolve complex process and product issues.
- Effectively delegates work to direct reports and manages through to successful completion.
- Analyzes quality audit findings and recommends improvements in products or processes. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements.
- Drives business improvements through mentoring and support for the continuous improvement initiatives.
- Prepare the post market surveillance team for regulatory inspections and customer audits, ensuring that all necessary documentation, procedures, and personnel are in compliance.
- Serves as escalation lead for quality related non-conformances and CAPAs.
- Drives compliance cross functionally in alignment with the Business Units for collaboration and multi-site adherence to relevant regulatory requirements.
- Investigates and resolves quality system nonconformance's (defined during internal and/or external audits.
- Support the development of direct reports through ongoing mentoring and coaching.
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Director Quality Engineering, Post-Market Surveillance - Andover, United States - embecta
Description
embecta is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of approximately 2,000 employees around the globe. For more information, visit or follow our social channels on LinkedIn, Facebook, Instagram and Twitter.
Lead and oversee the global quality post market surveillance functions at embecta. This role requires deep industry knowledge and expertise in quality assurance and familiarity with Regulatory requirements globally. Key skill and experience in complaint handling processes and tools is required. Reporting directly to the Vice President of Global Quality Assurance this role will provide strategic direction and operational leadership to the Designated Complaint Handling Unit (DCHU)
Responsibilities:
Bachelor's Degree or equivalent experience in Engineering disciplines and practices.
embecta is an Equal Opportunity/AffirmativeAction Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
