Flownamics, Inc., located in Madison, WI, is the worldwide leader in on-line sampling systems for biotech and pharmaceutical companies. We are seeking a detail-oriented and organized individual to join our team as a Quality Control Manager.

As a Quality Control Manager, you will play a crucial role in the quality performance of Flownamics products. The Quality Control Manager is responsible for the overall quality assurance of Flownamics products, ensures implementation of quality systems and compliance with applicable regulations, guidelines, and quality system procedures. This position requires strong analytical skills, experience with systems and data analysis, reliable attendance, and a keen eye for detail.

Discover a work experience where you can learn and grow as we increase our workforce. Rapid job advancement opportunities. Office hours are 8 AM to 5 PM Monday through Friday.

Flownamics offers competitive benefits, including additional paid time off (beyond employee PTO), to all full-time employees following a 90-day probationary period:

• Paid 5 day weekend the week of July 4th
• Paid 5 day weekend the week of Thanksgiving
• 1/2 day paid time off the Friday before Memorial Day
• 1/2 day paid time off the Friday before Labor Day
• Paid time off 12/23/2024 through 1/3/2025

Quality Control Manager Responsibilities:

• Working with the Engineering and the Production teams, establishes and implements quality control procedures and standards for inspections of raw materials, in-process, and finished products stages
• Verify the accuracy and completeness of receipt documentation for incoming materials.
• Partner with Production to ensure effective administration of QA documentation and adherence to product labelling requirements
• Perform review of Quality Control testing records to identify any discrepancies or non-conformities
• Implement corrective actions to prevent poor quality
• Participate in regulatory inspections and/or external client audits
• Primary auditor contact for external client audits
• Deliver solutions to quality and technical areas such as investigations, root cause analysis, and risk management tools, and making data driven and technical decisions, using critical thinking skills
• Reviews Supplier responsibility Non-Conforming Material reports and dispositions material in a timely manner, working with Engineers and Purchasing as required
• Records quality measures and analyzes performance using statistical process control methods
• Conduct gap assessments with effective procedures and ensure compliance within document control
• Assist with reporting to top management on the performance and integrity of the QMS and needs for improvement
• Manage and maintain all controlled company documents
• Write, revise, review and approve standard operating procedures
• Develop and prepare metrics to measure and drive continual improvement
• Arranging internal audits according to schedule, preparing timely and accurate audit reports, issuing and closing out findings, and elevating issues related to audit findings as needed
• Supports the supplier qualification program by participating in assessments and leading third party audits

Quality Control Manager Desired Qualifications:

• Bachelor’s degree in Science, Technology, Engineering, or Mathematics—or a related field of study
• 3-5 years prior work experience in a quality role, within a manufacturing or biomanufacturing organization, under a cerified or regulated environment (e.g. ISO, GMP, FDA)
• Experience with Quality Management Systems
• Advanced knowledge of quality improvement tools and techniques (i.e., Lean, Statistical Process Control, ISO9001)
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Demonstrated communication, organization and project management applying critical thinking
• Must be able to multi-task and be deadline oriented in a fast paced environment
• Experience with Microsoft Office Suite

Job Type: Full-time

Pay: $85,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to Relocate:

• Madison, WI 53718: Relocate before starting work (Required)

Work Location: In person