Quality Technician

• Monitor and maintain the state of inventory quality equipment maintenance calibration and facilities to ensure they comply with QS and cGMP requirements.
• Drive quality and compliance adhering to all Quality System documentation requirements and establishing/supporting plans to exceed Niowaves goals for Quality Safety Compliance On-Time Delivery (OTD) and financial objectives.
• Support internal and external audits.
• Support validation of test methods monitoring processes and equipment.
• Support production teams in product/material hold release disposition and traceability assessments and implement improvements to reduce recurring deviations that lead to rework or scrap.
• Support new product introduction (NPI) quality activities including prototype testing process validation and technology transfer to ensure successful product launches.
• Collaborate with cross-functional teams to support and solve production and quality challenges.
• Collect monitor analyze and communicate data to provide insight on quality metrics set by the management team.
• Support product/material hold release disposition and traceability assessments.
• Implement improvements to reduce recurring deviating events.
• Perform tolerance nonconformances deviations complaints and CAPA investigations.
• Execute document revisions and change control procedures.
• Perform inspection and disposition of regulated incoming materials.
• Perform data collection and analysis utilizing Environmental Monitoring equipment.
• Support Quality Assurance Specialists (QAS) with completing quality checks and approvals on production records.

• Associate or bachelors degree or equivalent in science or other related field.
• 3 years related experience with a solid understanding of regulatory compliance related to operations and quality procedures.
• Experience in quality assurance or quality control roles within a manufacturing or industrial environment.

• Experience with electronic quality management systems.
• Embraces & models the Niowave Values of Teamwork Courage Integrity and Upright Zeal.

• Understands how to integrate into a new team/organization appreciates the history of current state know how and when to make suggestions as well as using just the right pace to reach the improved future state.
• Understands your own communication and learning styles can assess others styles and is able to find the right path to connect the two.
• Resilient self-starter who learns and acts quickly within a rapidly evolving environment.
• Demonstrates excellent organizational and project management skills for self and teams
• Strong computer literacy (Microsoft Office Adobe)
• Excellent analytical skills and problem-solving skills with the ability to critically interpret and use data to manage risk.

• Bachelors degree or equivalent in science engineering or related field.
• 5 years relevant experience with a solid understanding of regulatory compliance related to operations and quality procedures.
• Experience in a facility with radiation regulatory requirements and/or quality role in the pharmaceutical or medical device industry.
• Experience with Minitab JMP or analytical tool software.
• Experience in audits (internal NRC FDA etc.)

• Full-time position.
• Companys standard operating hours are Monday thru Friday 6a 6p with production related activities requiring 24/7/365 shifts.
• This position will be assigned to a shift rotation.
• Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role.

Required Experience:

IC