Title:  Senior Quality Engineer - Fixed Term Contract

Job Summary

Provide support for the validation program for the plant or assigned functional area regarding equipment, processes or procedures used. Ensure compliance to regulatory and ISO Management standards.

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.
• candidate shall 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.
• Other duties as assigned. #LI-AP1 #LI-ONSITE

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.

Travel Requirements

Physical Requirements

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.

What We Offer