The company is looking to ensure the development and production of products meets customer and internal quality deliverables.
Requirements
- Experience with technical writing, IQ/OQ/PQ is preferred
- Experience with equipment validation is preferred
- Ability to apply advanced mathematical concepts and intermediate statistical (SPC) knowledge.
- Six-sigma experience, training or certification preferred.
- Intermediate level computer skills, including Microsoft Office applications required.
- SAP experience preferred.
- Experience in the Medical Device industry strongly preferred (ISO13485)
Responsibilities
- Coordinate and manage the execution of validations and creation of written protocols.
- Coordinate and manage the execution of change control activities.
- Assess results of Customer Complaint investigations and Corrective Actions for application, validity and conformance to FDA regulatory, QSR, ISO and Customer requirements.
- Develop and analyze statistical data in relationship to assigned tasks to determine adequacy of present standards and establish proposed quality improvements.
- Evaluate compliance using relevant information and individual judgment to determine whether events or processes comply with specifications, operating procedures or standards.
- Develop product specifications for existing products and assess existing specifications for accuracy and compliance.
- Plan, coordinate, and manage assigned Supplier Quality evaluations through scheduling and auditing of suppliers.
Other
- Assists the Quality Manager in coordinating and executing objectives throughout the company in cooperation with other departments.
- Interact with customers to assure mutual interpretation of specified requirements to ensure fulfilment of customer requirements and objectives are met.
- Assist the Quality Managers during customer audits and lead to final resolution any findings/observations resulting from the audits.
- Ability to work independently from verbal and/or written instructions required.
- Ability to understand and articulate how individual role and responsibilities tie into Quality department function, goals and objectives
- Bachelor’s degree in Engineering, Science or related field required
- 3+ years' of experience in a Quality position strongly preferred.
- Excellent communication skills with the ability to understand, read, write and speak English required.
- Up to 25% travel required (some international)
- Ability to regularly lift up to 30 lbs with repetitive movements.
