Title:  Sr Quality Engineer

Job Summary

In this role, the Senior Quality Engineer provides quality direction, governance, and Quality Management System best practices to syringe and drug containment programs.  This is a global role that will oversee multiple concurrent projects to ensure regulatory and quality compliance is maintained throughout the product development lifecycle into manufacturing and sustainment. 

This role will ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements according to the intended distributed markets.  They will partner with R&D, Regulatory, Supplier Quality, Analytical Labs, Supply Chain, and Operations to ensure consistency across product platforms which promote development and manufacturing high volume efficiencies and ensure product platforms are compliant with regulatory and business requirements throughout the complete development lifecycle including commercialization, sustainment, and post market surveillance activities. 

The incumbent will be a strong advocate for product, process, and system quality at all stages of product realization. This role is also responsible for Quality oversight of documentation submitted to regulatory authorities in support of commercial launch and life-cycle management.

Essential Duties and Responsibilities

• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Product Development, Risk Management, and Manufacturing:
  • 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.

Additional Responsibilities

• Quality Management System:
  • 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

Work Experience

• Bachelor Degree in Engineering or Science required
• Minimum 6 years of experience in a regulated industry (e.g., Medical Device), including Product Development, Product Manufacturing, and Post Market Surveillance Activities
• Relevant work history and/or experience may be considered in lieu of degree
• In-depth knowledge of cGMP regulations, ISO 11040, ISO 15378, ISO 13485, 21 CFR 820, ISO 14971, EU MDR

Preferred Knowledge, Skills and Abilities

• ASQ certification (CQE or CQA)
• Green or Black Belt certification
• 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
• 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

License and Certifications

• Manufacturing\Six Sigma Green Belt Certification or Black Belt Upon Hire preferred
• Quality\Certified Quality Engineer - ASQ (CQE or CQA) Upon Hire preferred
• ISO 13485 Auditor or Lead Auditor Training / Certification Upon Hire preferred

Travel Requirements

Physical Requirements

Additional Requirements

• Observe and interpret situations, analyze and solve problems
• Effectively communicate and interface with various levels internally and with customers
• 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