Sr. Quality Engineer II

How will you make an impact?

The Senior Quality Engineer is tasked with creating and maintaining documentation by promoting efficient QMS processes to meet regulatory requirements and supporting company business initiatives; a compliance mindset is needed. Will serve as the Quality Systems SME for the Burlington facility with responsibility to support the other Glaukos facilities as needed. The Quality Engineer ensures documentation reflects risk-based decision making and actions taken by the team to address quality issues/events in a timely manner. Excellent attention to detail is required to be successful as well as the ability to multi-task and prioritize. The engineer is responsible for working collaboratively in the organization's Quality Systems and its users, be engaged and provide support in the following areas but not limited to: CAPAs, nonconformances, metrics and the quality internal audit programs under the direction of the Quality Systems Manager.

What will you do?

• Oversee and ensure timely completion of nonconformances and also serve as the final QA approver of nonconformances.

• Oversee timely and quality completion of the CAPA records, primarily for Burlington facility and serve as the final QA approver for low to medium risk CAPAs.

• Scheduling regular occurring meetings to review and drive to completion open QMS records and generate timely meeting minutes.

• Support administration of the external regulations and standards program for the global organization, which requires collaboration at all levels and departments within the organization.

• Supporting NC and CAPA owners by leading or assisting individuals in root cause analysis, investigations, and/or determination of appropriate corrections as well as corrective and preventive actions.

• Ensuring when executing approval of Quality System documents all regulatory and internal requirements are met.

• Conducting in-person internal audits effectively and timely.

• Leading and managing backroom activities during external audits by regulatory bodies.

• Support auditees for appropriate, on time completion of audit findings by tracking audit finding due dates.

• Providing guidance on the appropriate use of the TrackWise Digital system, through to record closure for various quality system records.

• Interfacing with all GxP departments to ensure the quality system is implemented and effective.

• Leading groups in improvement projects to ensure continued compliance of the quality system as well as process optimization such as Operational Excellence/Lean Six Sigma activities.

• Collects, analyzes and disseminates key performance data and indicators from processes for monthly metrics meetings and semi-annual management reviews.

• Works with regulatory affairs to ensure Quality Systems are compliant to meet the organization's obligations.

• Supports implementation of the quality management system and ensures compliance to the QSR, MDD, MDR, ISO 13485, 21 CFR parts 4, 11, 210, 211, 820, and the organization's Quality Manual.

• Executes Change Management and document change processes, as needed to support initiatives.

• As needed, support the supplier and distributor audit program.

• Being onsite and provide in person support.

• Cross-functionality - Assisting in other QMS systems and processes to support key functions as needed.

How will you get here?

• Bachelor's Degree in Engineering, Science, or related field.

• 8+ years of relevant work experience; 5+ years medical device experience required.

• Minimum of 5 years of related experience with demonstrated knowledge in root cause analysis, technical/investigational writing, and internal auditing.

• Preferred to have 2 years experience as final QA Approver of Quality Systems related documentation such as but not limited to change controls, deviations, nonconformances, internal audit reports, CAPA reports, document change reports, protocols, technical reports, project plans, and quality improvement plans.

• Must have excellent documentation, collaboration, and communication, and time management skills.

• Attention to detail and accuracy is a must.

• Pharmaceutical or Medical device experience and minimum working knowledge 21 CFR part 210/211 and/or ISO 13485.

• Demonstrated experience using electronic GXP software systems such as TrackWise Digital, Oracle, Veeva Vault.

• A working knowledge of the Microsoft Office suite of products (Excel, PowerPoint, Word) needed.

• An advanced knowledge of data analysis with Excel is preferred.

• Team player, good written/oral communicator.

• Able to work independently and thrive and adapt to company culture.

• Must be organized and able to coordinate activities with internal departments and outside vendors.

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