We are seeking a Quality Engineer to support production. We offer a close-knit working group, relaxed atmosphere and competitive pay. The position is full time, direct hire. All candidates must live locally with authorization to work in the US for any employer.
The primary responsibility of this position is to identify, monitor and improve quality metrics and processes. This position actively participates in value stream team activities to ensure that the manufacturing processes are compliant with company procedures as well as FDA/ISO regulations and standards. The incumbent will serve as a technical resource to product development, manufacturing and suppliers to improve process capability, reliability and the quality of products. Will create quality and process improvement plans and drive root cause analysis activities.
- Ensure adherence to Quality System requirements in an FDA and ISO regulated environment throughout product and process lifecycle. This includes products in design and development as well as products in production and the processes which support them.
- Perform investigations and root-cause analysis activities as they related to Corrective/Preventative Actions (CAPA), and drive continuous improvement.
- Perform analysis, trending and reporting of inspection and test data to insure conformance to specifications.
- Facilitate process validation studies in conjunction with R&D, Engineering and Manufacturing to ensure compliance to applicable standards. Ensure validation and revalidation of production cells by evaluating equipment and processes for critical and non-critical parameters, performing capability studies and integrating findings into validation protocols.
- Ensure compliance in manufacturing areas and escalate nonconforming situations. Initiate and lead root cause investigations and documentation for non-conformities. Review dispositions of non-conformities for compliance and presence of objective evidence.
- Perform in-house failure investigations to determine deficiencies in product design and manufacturing processes.
- Identify, initiate and lead process, yield and compliance improvement. Implement improvements and methods for measuring effectiveness of changes. Train operations personnel where needed.
- Compilation and analysis of information for Quality Management Reviews and external audits. Perform trending on key Quality System metrics.
- Bachelors in Engineering, Biomedical, Life Sciences or similar
- 2 years of related industry experience
- Familiarity with QSR (FDA) & ISO Standards
- Design and Process Validation Experience
- ASQ QE Certification desirable