Role: Sr. Quality Engineer
Duration: Full Time
Location: Neenah WI
Required Skills: DOE, Validate, FMEA, Gage R&R, medical device, ISO 13485, ISO 9001, and Regulation 21 CFR Part 820, Part 803, GMP, HACCP
Our Fortune 500 client is looking for Sr. Quality Engineer based out of Neenah WI
Provides high-level Quality/Regulatory leadership for assigned critical and complex quality systems, developing and improving those systems to deliver business results, routinely checking for compliance with standards, and providing training to customers/stakeholders.
• The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
• Provides guidance for one or more critical/high-risk quality systems (Process Validation) making decisions on changes to standards, auditing system users (including Quality, R&E, Manufacturing Sites, and other Enterprise functions) for compliance to standard, training users on the standard, and supporting targeted implementation as needed to deliver business results
• Provides Validation and Process Change Control support to Project Teams and Manufacturing Quality Teams, including writing, reviewing, executing, and approving Validation protocols, as assigned.
• Initiates and follows up on CAPAs related to the assigned systems
• Identifies need for, develops, and executes continuous improvement plans for assigned systems
• Takes leadership of, or supports, the development and deployment of strategic quality management plans, initiatives and measures for assigned systems
• Works with Quality Leaders and other Functional Leaders such as Research & Engineering to build Validation-related capability at all levels of the organization to ensure sustainable quality results.
• Leads or supports assessments of required facilities, functions and suppliers to provide an independent and expert viewpoint. Uses the assessment process to build capability, drive continuous improvement, mitigate risks and ensure compliance to client requirements and external laws and regulations
• Ensures that established manufacturing inspection, sampling, and statistical process control procedures are followed, as applicable
• May lead or support the implementation of medium to large business initiatives
• Provides practical solutions and advice to any issues observed
• Manages self in accordance with the One client Leadership Behaviors
• A Bachelor’s Degree in a relevant field, typically science or engineering-related
• 8 years of broad experience in a Quality, Manufacturing, Research, or Regulatory function
• Six Sigma Certified Black or Green Belt, or ASQ-Certified Quality Engineer Certification is preferred
• Experience with Design of Experiments (DOE), Process Characterization and Validation, Gage R&R, and Risk Management tools (e.g. FMEA) is required
• Strong analytical skills including statistical analysis are required
• Experience with Batch/Blend, Cleaning & Sanitization, and Clean In Place validation to Cosmetic or OTC Drug standards is preferred
• Understanding and application of appropriate medical device regulations, requirements and standards (including USFDA, Health Canada, TGA) as well as knowledge and experience with ISO 13485 and ISO 9001, and Regulation 21 CFR Part 820, Part 803) is required
• Requires direct experience in executing the Quality Management System within a manufacturing environment, demonstrating an understanding of major quality management processes and practices such as GMP standards, HACCP, statistical quality control, product testing and internal quality auditing
• Cross functional team experience, including general knowledge and experience of Quality Management application within other functions such as R&E
• Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change management
• Manages time working on multiple projects simultaneously
• Can communicate in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor
Please send your updated word format resume along with your best contact details to firstname.lastname@example.org or call me at 201-244-4303
BSC Solutions Inc., is a Global IT Solution provider headquartered in Troy, Michigan with operations in the US, India and the Middle East. BSC Solutions has over 15 years of IT and consulting experience to give cost effective solutions to many Fortune 1000 companies.
Thanks & Regards,
Sr. IT Recruiter
BSC Solutions, Inc. USA | DUBAI | INDIA
1000 John R. Rd, Suite 203, Troy, MI 48083