Job ID :
US - Virginia - Middletown
- Serve as the primary interface between the Value Stream and Quality Assurance
- Provide support to the Value Stream in investigating nonconformances, audit findings, CAPA, complaints, environmental alerts and SCARs by conducting risk assessment and root cause analysis and determining corrective actions.
- Provide support to Quality Assurance in resolving NCRs and DRs, determining material dispositions, identifying supplier-caused problems and initiating SCARs to suppliers.
- Assist in the preparation and approval of COs related to the operation and improvement of the Value Stream processes.
- Drive continuous quality improvement in the processes related to the Value Streams. Maintain and monitor appropriate metrics to measure Value Stream quality performance. Determine continuation of the validated process state and initiate revalidation activities as necessary.
- Support the Value Stream and Engineering by ensuring manufacturing processes and equipment have sufficient capability to meet customer requirements by analyzing capability studies, control charts and other statistical data.
- Ensure equipment used by the Value Stream is properly validated, calibrated, maintained and verified in the calibrated or validated state.
- Support development projects, transfer projects, process changes and engineering projects in the Value Stream to provide overall quality assurance as it relates to quality standards, inspection techniques and frequencies, statistical analysis, testing, validations, and risk assessments (FMEAs).
- Assist in training and maintaining compliance to regulations and procedures.
- Other related tasks as assigned by Management.
- Bachelor’s degree in Science or Engineering or related discipline.
- ASQ certified engineer and ASQ certified auditor preferred. Six Sigma/Lean certified preferred.
- Minimum of 5 years quality experience with a medical device company.
- Knowledge of global regulatory and quality requirements associated with medical devices.
- Working knowledge of ISO 13485:2003, 21 CFR Part 820, IVD Directive and Canadian MDR.
- Experience in formal problem solving in a team environment.
- Detail oriented and has the ability to lead multiple projects and activities assigned.
- Excellent organizational skills, planning, communication and follow up skills.
- Proficient in Microsoft Word and Excel. SAP experience preferred.
- Normal office and manufacturing environment.
- Position will require frequent communication with and walking to other areas in which designated PPE will be required.
- Position will require prolonged sitting and standing.
- Employee may occasionally lift and/or move up to 25 pounds.