Vacancy expired!
Lead the management of assigned Contract Manufacturing Organizations (CMOs) as the main point of contact, overseeing technical manufacturing responsibilities of the CMOs. Key Responsibilities: Review and approve Contract Manufacturing Organizations (CMO) changes through the company's Change Management system. This Process includes ensuring validation / qualification of equipment, (including software), processes, and material changes are adhering to regulatory requirements. Partner with CMOs to develop complex experiments and tests (including writing and executing protocols) to qualify and validate new manufacturing processes; analyze results, make recommendations, and develop reports. Identify opportunities to reduce cost at CMO, driving Value Improvement Projects (VIP) and reporting progress to management. Develop business cases at existing or new CMOs to promote business continuity, risk mitigations, supply chain improvements, etc. Collaborate with the company's Quality Labs (EQL) to perform Biology, Chemistry, and Microbiology test studies for applicable changes submitted by CMOs. Identify Opportunities to optimize moderately complex CMO Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities at the CMO for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk. Support product/process transfer projects to assure compliance with procedures, as well as facilitation of activities required in the transfer. Partner with Quality Engineering to do on-site line walks and shadow audits as a third-party observer. Develop, update, and maintain technical content of risk management files, drawings, and other DHF documents. Responsible for following appropriate procedures and meeting regulatory compliance requirements. Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations) Lead and establish project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.) Other incidental duties assigned by Leadership Basic Qualifications:
- Bachelor's Degree in Engineering or Scientific field
- 5+ years of experience, including industry or education
- Aerospace, Med device, Pharma, Manufacturing, Automotive
- Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
- Proven expertise in usage of MS Office Suite including MS Project;
- Basic understanding of statistical techniques
- Previous experience working with Suppliers and Contract Manufacturers is a plus
- Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
- Strong problem-solving, organizational, analytical and critical thinking skills
- Substantial understanding of processes and equipment used in assigned work
- Good leadership skills and ability to influence change
- Knowledge of applicable FDA regulations for medical device industry
- Strict attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- Must be able to work in a team environment, including inter-departmental teams and key contact represententing the organization on contracts or projects
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Vacancy expired!