Title:  Senior Quality Engineer, Integrated Systems

Job Summary

In this role, the Senior Quality Engineer provides quality direction, governance, and Quality Management System best practices to syringe systems and drug containment programs.  This role is responsible for performing and overseeing the operation and assembly of syringe systems, ensuring compliance with quality standards and regulatory requirements. This role will oversee assembly of Systems in West Waterford (WFD) labs, serve as a liaison with WFD labs, support complaint handling, investigations, and provide general QMS support as needed.  
The Senior Quality Engineer will provide general support for the Quality Management System (QMS) in the context of regulated medical products, ensuring adherence to industry standards such as ISO 15378 and FDA/EU/ROW regulations. In addition, the Senior Quality Engineer will support document control activities.  
This role is also responsible for performing complaint handling and investigations related to product quality issues, conducting root cause analysis, and leading corrective and preventive action (CAPA) processes. The role also includes providing ongoing support for the quality system, ensuring it aligns with both internal and external requirements, and working cross-functionally to implement process improvements. The Senior Quality Engineer will also participate in audits, support regulatory submissions, and assist in maintaining product documentation to ensure compliance with regulatory agencies. 
The successful candidate will have a strong understanding of quality engineering principles, excellent problem-solving skills, and the ability to manage multiple priorities in a fast-paced, regulated environment. Effective communication and relationship management skills are essential for collaborating with cross-functional teams, stakeholders, and regulatory bodies.

Essential Duties and Responsibilities

• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Syringe System Operations and Risk Management (Assembly, Testing, Kitting):
  • Partner with global cross-functional stakeholders to ensure syringe systems are assembled, tested, kitted, and distributed according to product specifications
  • Perform and drive complaints and investigations related to product quality issues to completion, including but not limited to conducting root cause analysis, and leading corrective and preventive action (CAPA) processes.
  • Manage the relationship with and partner with the WFD testing laboratory to ensure syringe systems and components comply with product specifications and applicable regulatory requirements, ensuring effective testing, validation, and analysis of syringe systems. Partner with the laboratory team to resolve product complaints and investigations as part of post market surveillance activities.
  • Partner with R&D to provide Quality Engineering direction to multiple concurrent product development programs to ensure product & process compliance to all applicable regulatory and cGMP requirements, ensuring sustainable and scalable solutions.
  • Author, review, and/or approve design history documentation and design manufacturing documentation (e.g., product specifications, design verification & validation activities, FMEA risk documents, test methods, protocols, reports, manufacturing records, etc.) 
  • Oversee and provide direction to cross-functional teams on product development DHF/DMR documentation including but not limited to failure analyses, risk management activities, FMEAs (application, design and process), process flow analyses, design of experiments, process capability analyses, quality inspection procedures including sampling plans, and test method validation
  • Lead the development and maintenance of product or process risk and hazard analysis in accordance with West policies and procedures.
  • Partner with R&D to ensure successful design transfers of new or updated products and manufacturing transfers from Product Development into Manufacturing, in collaboration with Operations and third party providers.
• Quality Management System:
  • Provide Quality Systems support to the Integrated Systems Operating Unit as needed to facilitate document release and control.
  • Lead and manage QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings, issue reviews, document control, change controls, configuration management, etc.  Provide direction on any nonconformance, deviation, or excursion that may occur and drive to closure. Author and review product development QMS procedures and work instructions
  • Drive proactive, preventative behaviors and via a strong CAPA and to resolve product quality issues for commercialized products.
• Miscellaneous:
  • Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS. 
  • Drive continuous quality improvement projects
  • Other duties as assigned

Education

• Bachelor Degree in Engineering or Science required
• Relevant work history and/or experience may be considered in lieu of degree.
• Minimum 6 years of experience in a regulated industry (e.g., Medical Device), including Product Life Cycle Management, Product Manufacturing, and Post Market Surveillance Activities

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Preferred Knowledge, Skills and Abilities

• In-depth knowledge of cGMP regulations, ISO 11040, ISO 13485, 21 CFR 820, ISO 15378, ISO 14971, EU MDR
• Experience with MasterControl, SAP, Share Point, Teamcenter
• Experience with EU GMP Annex I, and PDA a plus
• Expertise in quality management tools. Standards, policies, and procedures – APQP, PPAP, MSA, SQC etc

License and Certifications

• In-depth knowledge of cGMP regulations, ISO 11040, ISO 13485, 21 CFR 820
• Manufacturing\Six Sigma Green Belt Certification or Black Belt Upon Hire preferred
• Quality\Certified Quality Engineer-ASQ (CQE or CQA) Upon Hire preferred
• Experience with MasterControl, SAP, Share Point, Teamcenter
• Experience with EU GMP Annex I, and PDA a plus
• Expertise in quality management tools. Standards, policies, and procedures – APQP, PPAP, MSA, SQC etc

Travel Requirements

Physical Requirements

Additional Requirements

• In-depth knowledge of cGMP regulations, ISO 15378, ISO 14971, EU MDR
• Strong communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
• Excellent written, critical reading, effective problem solving, 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
• Proficiency in standard project management tools and software (e.g. Microsoft Project, Excel) for planning, tracking, and reporting project activities.
• Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
• Be aware of all relevant SOPs as per Company policy as they relate to this role
• Able to comply with the company’s safety policy at all times
• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations
• Maintain high attention to detail, accuracy, and overall quality of work
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems
• Effectively communicate and interface with various levels internally and with customers