Mfg/Ops Quality Engineer 1

Illumina•San Diego, CA

4d•Onsite

About The Position

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.

Requirements

Bachelor's Degree required.
Engineering and/or Science Degree, preferred
0-2 years experience in quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic manufacturing preferred
Knowledge and experience applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD)
Knowledge and experience with instituting quality controls in an ERP system, SAP preferred
Highly effective communication, facilitation and negotiation skills
Adaptable to fast-paced, dynamic work environment with shifting demands

Responsibilities

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 Illumina sites.
Other activities as assigned.