Quality Systems Program Manager
Flexible & Integrated Technical Services
- Juncos, PR
- Permanente
- Tiempo completo
- Bachelor’s Degree in Engineering or Sciences and five (5) years of experience within the Medical Devices Industry.
- Bilingual: Spanish and English
- Soft Skills: Negotiating and Conflict Resolution skills
- Shift: 1st, 2nd, and according to business needs.
- Experience in:
- Risk Management/Critical Thinking
- Hands-on Experience on Projects/Scheduling for Medical Device manufacturing.
- Leading cross-functional team and leveraging solid PM skills (project planning, communication, risk management).
- Problem solving methodologies (DMAIC, process map, 5 whys).
- Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?
- Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Works directly with operating entities to provide process analyses oversight, continuingly to enforce requirements and meet regulations.
- Leads audit and inspection preparation, resolution of audit and inspection findings, and liaises with auditing groups and inspectors through all stages.
- Prepares reports and/or necessary documentation (ex, Corrective and Preventive Actions) and provides to applicable stakeholders.
- Co-ordinates legal requests in support of government investigations or litigations.
- Ensures the quality assurance programs and policies are maintained and modified regularly.
- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of the company's mission globally.
- Is accountable for the overall program process, performance, and customer satisfaction.