Job Title

Program Manager – Plant Transfer

Relevant Experience?

12 Years Medical Device Industry Experience

Vison care/ Surgical Vision Industry experience preferred

Technical/ Functional Skills?

1. SME of medical devices industry functions
2. Working knowledge of cGMP, FDA 21 CFR Part 820, ISO 13485 QMS requirements
3. Experience in successfully leading a medical device project from concept to market in FDA regulated industry
4. Regulated industry licenses, registration, change notification document preparation, technical file updates experience
5. Regulated industry audit, compliance activities, audit assessment and documentation experience
6. Good skills using the tools and techniques of Project Management.??
7. Experience of successfully managed multiple projects from conception through commercialization
8. Strong communication skills, both oral and written, to communicate effectively with customers and internal stakeholders
9. Ability to work effectively in a cross functional team environment and build strong working relationships
10. Understanding of the vison care products, surgical vision devices and procedures
11. Experience with Plant, product and process transfer activities

Experience Required

12 Years Medical Device Industry Experience

Vison care/ Surgical Vision Industry experience preferred

Roles & Responsibilities

1. Assessment of QMS functions to understand its impact due to plant transfer
2. Plant transfer quality plan development
3. Transfer coordination
4. Validation support to qualify cleanroom, Labs, and applicable utility systems?
5. QMS setup support: Impacted QMS functions procedure update and perform associated change management tasks
6. Labelling changes coordination and associated change management tasks?
7. Decommissioning plan development
8. Cleanroom & Lab equipment (transferred and new) qualification support
9. Support for supply chain impact assessment, purchase control QA activities, supplier management activities
10. Documentation support for ISO 13485/MDSAP/EUMDR certification, licenses, and registration, change notification documents, technical file updates
11. Support for internal quality agreements impact assessments and updates
12. Compliance activities support: audit assessment and documentation support

?

Education

Mechanical/Bio-medical Engineering

Master’s in Mechanical/Bio-medical Engineering Preferred

PMP certification Preferred

Work Location?

Santa Ana, CA

Key words to search in resume

• Hands on experience on Medical device Industry functions
• Working knowledge of cGMP, FDA 21 CFR Part 820, ISO 13485 QMS requirements
• Awareness on vison care products, surgical vision devices and procedures
• Experience in Plant, product and process transfer activities