Manufacturing​/Operations Quality Engineer

This position is responsible for manufacturing and product Quality activities. This role is within Mfg/Ops Quality organization and is accountable for supporting day-to-day sustaining activities in a manufacturing environment. The position requires exceptional communication, interpersonal, and project management skills to effectively coordinate activities and deliver results.

This position will have direct interaction with Manufacturing and Process Engineering groups to support manufacturing sustaining activities, continuous improvement, and manufacturing capacity expansion. The position may also have quality oversight for more than one manufacturing area. The position will be responsible to support change management activities, Nonconformances, equipment lifecycle, meeting facilitation and other ad hoc sustaining manufacturing requests.

• Provide ongoing quality engineering support throughout the product life cycle.
• Provide support to engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements.
• Ensures adequacy of non-conformances and QI/CAPA records, investigations, and corrective actions.
• Support process risk management activities and ensure quality and completeness of validation packages, and change orders.
• Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making.
• Review verification and validation reports and identify gaps for GMP compliance.
• Develop and execute strategies to close gaps in an efficient, technical, and compliant manner.
• Coordinate issue resolution using a risk-based approach.
• Ensure manufacturing processes and validation programs meet requirements of FDA and ISO.
• Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis.
• Collaborate with counterparts and cross-functional teams at other sites.
• Other activities as assigned.

• Bachelor’s degree in an engineering discipline.