Senior Specialist, Production

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate - which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day - our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

**Job Summary**:
**Essential Duties and Responsibilities**:

- Plan and control production activities to ensure that products and services conform to the requirements of our customers and provide full customer satisfaction. The principal objective is to supply products that are cost-effective without prejudice to the required standard of safety, quality, performance, reliability.
- Develop and maintain safety protocols and procedures to ensure the safety of all personnel involved in the production processes.
- Lead and facilitate safety training and awareness programs for production staff and ensure compliance with safety regulations.
- Drive and participate in risk management activities related to manufacturing processes, identifying and mitigating potential safety hazards, and implement solutions & controls.
- Instill discipline and safety mindset in the manufacturing areas and facilitate the coordination with the various functions to achieve synchronization in the approach and practices on safety.
- Develop, review, and implement procedures to ensure effective enforcement of the right practices throughout all the processes to meet the required quality of medical devices and its legal compliance with the regulatory requirements (e.g., FDA regulations, ISO 13485)
- Create and/or modify work instructions, technical documents, engineering studies, and deviation (non-conformance) reports as and when needed.
- Resolve customer related problems and/or issues as and when needed, and take responsibility in closing out internal quality and CAPA related actions, in collaboration with the Quality department.
- Develop and maintain metrics to measure and track production quality and output performance, and implement continuous improvement initiatives based on these metrics.
- Lead cross-functional teams to resolve quality-related issues and implement CAPAs.
- Support Lean Sigma initiatives and actively drive for waste reduction and quality improvement.
- Ensure cGMP and “6S” discipline in the manufacturing areas and facilitate the coordination with various functions to achieve synchronization in the approach and practices in quality.
- Lead and facilitate complex projects related to process improvements, capacity expansion, and on-time delivery of products.
- Develop and maintain metrics to measure and track production efficiency, collaborate with cross-functional teams to ensure the harmonization and well-coordination of the workflow to achieve optimized performance and on-time delivery targets, and implement continuous improvement initiatives based on these metrics.
- Support the establishment of systems to drive and measure production, quality and people performances in order to ensure the continuous improvement of the production performance in all areas.
- Support projects related to process improvements, cost reductions/savings, scrap reductions, etc. through the implementation of LEAN concepts
- Collaborate with Engineering, Operations, Quality, Laboratory, and other supporting functions or vendors to assess, validate and improve processes related to current and new components for assigned area.
- Coordinate and/or perform necessary validations and/or process engineering evaluations as and when needed for equipment, process, and material-related items.
- Understand key business drivers and follow applicable West Business System tools & methods in execution of assigned tasks.
- Establish and maintain an effective communication link to provide timely and accurate updates to the production personnel and feedback channels.
- Develop corrective and preventive action plans to improve quality and production performances.
- Support and contribute actively in Lean Sigma programs and activities towards the delivery of the set targets.
- Perform duties as required by the Superior.

**Basic Qualifications**:

- Bachelor's degree in Mech