Mfg/Ops Quality Engineer 2

Target Pay Rate: 35.50–44.25/hr **salary will be commensurate with experience

Position Summary:
This position is responsible for manufacturing and product Quality activities including direct interaction with the Manufacturing and Process Engineering groups to support manufacturing sustaining activities, continuous improvement, and manufacturing capacity expansion. This role is within Mfg/Ops Quality organization and is accountable for driving change, establishing sustainable processes, improving products, providing actionable process and product data, supporting risk management activities and development of process/product validation strategies, and sharing best practices. This position works on problems of limited scope, follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained, builds stable working relationships internally to effectively coordinate activities, completes assigned actions on time according to plan, proactively communicates challenges in advance of due date(s), requires strong communication, provides supporting data to project lead on risk in area of responsibility, delivers results, and applies quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD, MDD) where appropriate.

Responsibilities:
- Provide ongoing quality engineering support throughout the product life cycle.
- Provide support to manufacturing functions for validation planning and transfer activities.
- Ensures adequacy of non-conformances and CAPA records, investigations, and corrective actions.
- Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making.
- Review equipment onboarding, calibration and preventative maintenance tickets and identify potential gaps for GMP compliance.
- Review change requests/notices/approvals for compliance to change requirements outlined in applicable WIs/Procedures.
- 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 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.
- Collaborate with counterparts and cross-functional teams at other client sites.
- Other activities as assigned.

Requirements:
- A minimum of 2 to 4 years of applied experience in the quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic manufacturing is desirable.
- Strong communication, facilitation, planning, problem-solving, and organizational skills.
- Demonstrated effective collaboration skills with teams in multiple/global locations is desired.
- Demonstrated ability or aptitude to learn how to manage and lead change.
- 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 desired.
- 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.
- Is considered a subject matter expert for assessing and resolving complex quality issues.
- Applied experience in meeting and applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, MDD, IVDD, and CMDR) desired.
- Experience with data mining, trend analysis, and 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/NC, Change Management systems).
- Background in nanoimprint lithography and/or surface activation chemistry a plus.
- Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Experience/Education:
- Bachelors degree in an engineering or scientific discipline.
- Work experience in a quality engineering role desirable.