The Senior Quality Engineer position will apply leadership, interdependent partnering, and Quality Engineering expertise to ensure efficient and effective quality & compliance and continuous improvement in our end-to-end business with a focus in manufacturing operations. They will apply these principles and problem-solving skills to develop and optimize products & processes that are aligned with the overall business vision. This individual will lead process containment and bounding of nonconforming product. They apply appropriate risk management to prevent unanticipated failure modes and improve capability of processes. They pioneer methods and techniques to be used or adapt standard methods to meet needs. They coordinate phases of work internally and externally, mentor more junior engineers, and may coordinate activities of technical support staff. This role supports new product introduction, continuous improvement initiatives, and base business products and processes.
Key Responsibilities:
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, GxP, and other applicable regulatory requirements
- Identifying and supporting resolution of Quality Issues. Owns and supports investigation, bounding, actions, reviews, and approval of non-conformances, CAPAs, and audit findings.
- Developing, tracking, and reporting quality metrics to improve Quality Systems.
- Conduct risk-based decision making and create and update risk documentation and manufacturing control plans.
- Use lean principles to make process improvements.
- Perform validation activities and support NPI projects as part of design transfer.
- Handle conflict resolution as it relates to technical situations.
- Coaching others on quality event investigation processes
Qualifications
Education:
- A minimum of a Bachelor’s degree in Engineering is required.
Experience and Skills:
Required:
- A minimum of 2 years of experience in a GMP and/or ISO regulated industry and experience with FDA regulated environment.
- Supporting a production environment.
- Process Validation expertise.
- Strong Technical Writing skills.
- Strong knowledge of statistical software packages and the ability to facilitate decision making practically, graphically, and analytically.
- Project management/leadership experience or certification.
Preferred:
- A minimum of 4 years of experience in a GMP and/or ISO regulated industry and experience with FDA regulated environment.
- Training or certification in Lean or Six Sigma Methodologies.
- Technical understanding of manufacturing and inspection equipment and processes.
- Strong organizational skills.
- Critical thinking and attention to detail.
- Excellent verbal communication skills.
- Ability to analyze and present data that facilitates & drives decision making.
- Perform “hands on” problem solving.
Other:
- Ability to proficiently communicate both verbal and written in English.
- This position will be located in Warsaw, IN and may require up to 10% domestic or international travel.
