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Mfg/Ops Quality Engineer 2

San Diego, CA 92122

Posted: 02/02/2023 Employment Type: Contract Job Category: Engineering Job Number: 542776 Is job remote?: No Country: United States

Job Description


Responsibilities:

This position is responsible for manufacturing and product Quality activities. This role is within Mfg/Ops Quality organization and is accountable for driving change, establishing sustainable processes, improving products, and providing senior management with actionable process and product data. The position requires communication, interpersonal and project management skills to effectively coordinate activities and deliver results. A solid understanding of the application of quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD, MDD) is preferred.

This position will have direct interaction with Manufacturing operations and Process Engineering groups to support manufacturing sustaining activities, continuous improvement and manufacturing capacity expansion. The position may also have responsibility for new product introduction (NPI)and/or quality oversight for more than one manufacturing area. This position will also participate in the sharing of best practices and lessons learned from NPI and Sustaining Quality.

Provide quality support to capacity expansion and new product development teams in the areas of process control, process verification and validation, design transfer, process validation, risk management, and specification development. Provide ongoing quality engineering support throughout the product life cycle. Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements. Ensures adequacy of complaint, non-conformances and CAPA records, investigations, and corrective actions. Provide consultation to end users and process owners with regard to data collection, analysis and creation of validation reports. 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 product 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. Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion.
Other activities as assigned.

A minimum of 2 to 3 years of applied experience in the quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic development and/or manufacturing. Strong communication, facilitation, planning, problem-solving and organizational skills. Demonstrated effective project management skills and collaboration on teams in multiple/global locations is desired. Good judgment and decision-making skills; knows how to make trade-off decisions while balancing compliance and business impact. Experience with quality and process improvement methodologies and tools. Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands. Ability to execute strategy, approach, methods and actions on new assignments. Applied experience in meeting and applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, MDD, IVDD, and CMDR). Effective data mining, trend analysis, statistical analysis. Experience with electronic product life cycle (PLM), enterprise resource planning tools (ERP), manufacturing execution systems (MES).Experience with enterprise Quality System tools (e.g., electronic CAPA, Complaint Management systems).Background in chemistry, biochemistry or a related engineering discipline is preferred. Background in oligonucleotide synthesis and surface activation chemistry a plus.

40-45 pay rate range
**salary will be commensurate with experience**

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