Manufacturing Quality Engineer

JOB SUMMARY

This position is responsible for manufacturing quality operation activities including, but not limited to, management of process improvements, verification and validation efforts, reliability testing, support of Quality Control inspection and testing, data analyses and trending and monitoring the effectiveness of the quality system.

This role will partner with R&D, Manufacturing and Engineering to drive harmonization and alignment of the company's methodologies related to equipment, process and test method validation. As part of the team, this role will significantly contribute to the implementation and maintenance of manufacturing quality engineering methodologies, systems, and practices and effectively integrate these practices into the development of the company's products.

The position will be a strong advocate for manufacturing quality at all stages of product realization. They will exhibit a strong "quality first" mentality and ensure that product quality is held to the highest standard, meets regulatory expectations and supports business expectations.

JOB RESPONSIBILITIES

• Manage continual improvement activities to enhance the quality system; investigate manufacturing product quality and compliance issues, identify opportunities for re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, collect relevant data, and reduce risk. Optimize processes using Six Sigma, Kaizen, Lean methods.
• Interface with R&D, Engineering and Operations to ensure proper testing and transfer to Production of new or modified products. Proactively identify technical issues and solutions.
• Ensure that relevant quality considerations are well defined and documented during new product design reviews
• Lead verification and validation activities using risk-based approach to ensure processes and equipment, test methods, as well as QMS software, are qualified and validated according to regulations and internal requirements.
• Develop master validation plans, protocols and reports for processes, equipment (IQ/OQ/PQ), and test methods. Oversee execution of validation activities. Partner with Software and Engineering teams as required.
• Define quality related equipment calibration and maintenance needs.
• Assess changes for potential impact on processes and their validation status; identify actions to remedy such impact (re-validation activities) perform product/process failure root cause analyses and support implementation of corrective actions.
• Participate and/or lead CAPA initiatives and investigations including root cause analyses, create and implement action plans and determine CAPA effectiveness.
• Support complaint investigations, recommend actions to address reported field issues and collaborate with other functions to determine true root causes, as necessary.
• Manage non-conformance reporting and disposition of non-conforming materials. Lead Material Review Board (MRB) meetings and maintain relevant matrices.
• Drive and facilitate Risk Management documentation to ensure compliance with ISO 14971.
• Work with cross-functional teams to develop process FMEAs based on corrective/preventive actions, complaints, and non-conformance reports.
• Prepare quality data analyses and trending reports for quality management reviews and complaint management reviews.
• Review and approve validation life cycle documentation (PDD, IQ/OQ/PQ protocols, protocol addendums, summary reports, etc.).
• Prepare quality control work instructions and train quality control inspectors on inspection procedures.
• Provide support and leadership to junior team members.
• Assume management duties in absence of the Quality Manager, as required.
• Other duties as assigned.

BASIC JOB QUALIFICATIONS & SKILLS:

• Minimum, Bachelor's Degree in engineering or science.
• Minimum, 5 years of related experience in medical device manufacturing.
• Working knowledge of Quality standards, i.e., QSR 21 CFR 820, ISO 13485 and ISO 14971.
• Demonstrated experience regarding inspection and test method validation.
• Ability to influence R&D, Manufacturing and Engineering organizations regarding quality requirements and industry best practices.
• Excellent written, critical thinking and oral communication skills.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Strong problem-solving skills including root cause failure analysis methods.
• Proficient in statistical software, Windows OS, Microsoft Office: Word, Excel, Power Point, and Teams.
• Be aware of all relevant SOPs as per Company policy as they relate to this role.
• Able to comply with the company's quality policy at all