Contract position: Engineering Program Manager needed in Marion NC for a medical device manufacturer. Will lead FDA Remediation for Major Capital Projects will function as the owner representative on major capital projects associated with remediation, providing consulting, and engineering and facilities project management services. This is a contract position expected to last 12 months, could be longer based on performance, possible temp to hire. Can offer per diem! Great Contractor Benefits! Apply Now!Responsibilities for the Program Manager
Requirements for the Program Manager
- Provide manufacturing engineering support for deliverables (based on Gap list); of the Device Master Record, including but not limited to, design specification, TMV and process validations, protocols, testing, reports, equipment qualifications
- Support Remediation product teams on manufacturing engineering related remediation, and process or equipment qualification, thorough review and approval of protocols, TMV and Validation protocols and reports
- Work with quality and manufacturing teams to review and update manufacturing work instructions, material specifications, and inspection documentation for sustaining products as needed
- Review and update inspection requirements, including identifying methods and sampling plans and evaluating inspection fixtures
- Participate in development of; process, equipment, inspection or new material qualifications.
- Initiate documentation or documentation changes (DCRs, Deviations, etc.) for products and processes as required to reflect validation/qualification activities and results
- BS degree
- 8+ years engineering or operations capital project management experience in the medical device or pharmaceutical industry
- Previous experience working on a FDA Remediation project(s)
- Working knowledge of FDA GMP and ISO 13485 requirements
- Knowledge of statistics and quality tools such as SPC, Risk Analysis, Process Capability, DOE, TQM methods, and Lean/Six-Sigma
- Paid Vacation
- Health Insurance, and more...
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.