Senior Quality Engineer - Fixed Term Contract

Essential Duties and Responsibilities

• Responsible for compliance to West's validation program.
• Ensure that the validation requirements are documented to provide direction for meeting the validation needs of the customers, associated regulatory bodies and West functional groups.
• Provide guidance to system/process stakeholders as to content and format of Validation life cycle documentation.
• Demonstrate hands-on experience planning, establishing and executing software validation activities.
• Support Engineering and Operations groups during the process development and Validation phases of customer products' life cycles.
• Provide required training to support qualification activities.
• Assume the QA responsibilities for reviewing and approval of validation life cycle documentation (PDD, IOQ/PQ protocols, protocol addendums, summary reports, etc.)
• Provide guidance during protocol incidents process, including reporting, investigations and approval of resolutions.
• Keep current with all Industry standard practices and FDA requirements for validation, change control and complaint handling.
• Monitor Change Control system and provide guidance for proper execution and timely closure of Change Controls and Action items.
• Understanding and facilitation of Risk documentation to ensure compliance with ISO 14971 and ISO 31000.
• Ensure compliance with Quality, Business Continuity, Safety and Environmental standards and applicable regulations.
• Experience with risk management and task prioritization a must for this role.

Education

Bachelor's Degree in Engineering or Science, or equivalent experience required.

Work Experience

5+ years of relevant work experience required.

Preferred Knowledge, Skills and Abilities

• 2+ years of experience writing, executing and summarizing protocols.
• Knowledge of FDA, cGMP, ISO and Clean Room standards.
• Knowledge of validation of automated assembly, software, and manufacturing processes.
• Knowledge of ANSI/ISO standards.
• Excellent written and verbal communication skills.
• Good problem-solving skills and be able to function independently or as a member of a team.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target.
• Able to comply with the company's safety policy at all times.
• Able to comply with the company's quality policy at all times.

License and Certifications

• Manufacturing\Six Sigma Green Belt Certification or Black Belt upon hire, preferred.
• Quality\Certified Quality Technician-ASQ (CQE or CQA) upon hire, preferred.
• ISO 17025 Auditor or Lead Auditor Training / Certification upon hire, preferred.

Additional Requirements

• Exhibit a strong "quality first" mentality and ensure that product and process quality are held to the highest standard.
• Excellent written and oral communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Strong problem-solving skills including root cause failure analysis methods.
• 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.
• Critical reading skills and 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.