About the role
Job Description Summary
The Quality Engineer II will assist the Manufacturing Departments in the establishment and implementation of programs designed to assure control of processes and products toward established quality standards. Use problem solving techniques to improve quality within the business.
Justification
Addition
Responsibilities may include but are not limited to:
- Ensure that all company safety rules and regulations are followed and promote general plant safety.
- Work with Process Engineering to implement plant driven changes and provide overall support of process improvements by working with engineering teams to implement process improvements to improve Quality, conducting quality improvement projects through various CI initiatives.
- Develop or update in-process inspection requirements to ensure the greatest value in process control for the customer and the plant during the manufacturing process while meeting regulatory requirements.
- Provide assistance in such areas as process/equipment validation, process and product acceptance, audit correction actions, Change Control issuance for process changes.
- Support CAPAs as owner or as part of the support team
- Monitor the performance of product lines for product quality metrics.
- Work to implement document changes in support of ongoing efforts to simplify internal quality procedures in alignment with business unit and corporate requirements.
- Leading investigations for quality issues resulting in large rejections by using applicable problem solving and root cause techniques.
- Complete training in order to support Manufacturing Quality for day-to-day operations including assuring product release, manufacturing quality training and defect containment. This also includes support of the 24/7 operation for manufacturing Quality.
- One week a month rotation.
- On call one week a month.
- Other duties, as assigned.
Education
- Bachelor's degree is required.
Experience
- 3 years manufacturing experience with broad background in manufacturing processes.
- 3 years practical GMP / Medical Device manufacturing experience.
- 2 years Quality manufacturing experience
- Strong interpersonal skills with ability to work in a team environment.