Nemera
Quality Engineer - Validation
Buffalo Grove, Illinois, United States
Work authorization required$85k-$105kDetected 148 days ago
StatisticsSAPAuditingSupply ChainProcess ImprovementFDA RegulatoryMedical DevicesCommunicationCollaborationProblem SolvingWritingMicrosoft Office
About the role
- The Quality Validation Engineer is responsible for planning, coordinating and managing through completion, assigned projects to ensure the development and production of products meets customer and internal quality deliverables.
- Duties and responsibilities are accomplished personally or through collaboration with other staff.
- We take pride in our work because it improves patients' lives.
Responsibilities
- Coordinate and manage the execution of validations and creation of written protocols.
- Coordinate and manage the execution of change control activities.
- Utilize CAPA problem solving techniques to reduce internal and external failures, selects sound techniques (FMEA, Design of Experiments, Cause and Effect, Flow Charts, SPC) to solve problems effectively, and assess results for application, validity and conformance to specifications.
- Develop and analyze statistical data in relationship to assigned tasks to determine adequacy of present standards and establish proposed quality improvements, including analysis of current inspection methods and sample plans.
- 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.
- Support implementation and management of quality agreements with assigned suppliers.
- Plan, promote, perform and organize training activities for internal departments related to quality activities, including basic statistics, DOE, GR&R and Sample Plan designation.
- Assist the Quality Managers during customer audits and lead to final resolution any findings/observations resulting from the audits.
Requirements
- Works in a clean manufacturing environment that may include moderate noise levels and required appropriate PPE and cleanroom apparel.
- Ability to travel between office and production departments as well as company buildings required.
- Up to 25% travel required (some international)
- Bachelor's degree in Engineering, Science or related field required
- Ability to regularly lift up to 30 lbs with repetitive movements.
- Ability to push and pull items.
- Ability to stand, sit, walk up to 80% of a shift.
Skills
- Bachelor's degree in Engineering, Science or related field.
- 3+ years' of experience in a Quality position strongly preferred.
- Experience in the Medical Device industry strongly preferred (ISO13485)
- Experience with technical writing, IQ/OQ/PQ is preferred
- Experience with equipment validation is preferred
- Experience working onsite in Manufacturing is strongly preferred
- Excellent communication skills with the ability to understand, read, write and speak English required.
- Must have the 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.
- Ability to work independently from verbal and/or written instructions required.
Compensation
- $85,000 - $105,000 USD Salaried (This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting.
- This range may be modified in the future.)
- This company is required by federal law to hire only persons who can establish they are eligible to work in the United States.
Benefits
- Support and maintain all policies of the company, including but not limited to applicable FDA regulatory and ISO requirements, Health and Safety Requirements and Continuous Improvement initiatives.
- Preferred/Required Education/
- For US Benefits, CLICK HERE.
Company info
- Interact with customers to assure mutual interpretation of specified requirements to ensure fulfilment of customer requirements and objectives are met.
This listing is sourced directly from Nemera's careers page and normalized into a canonical job model.