Merz Pharmaceuticals USA Racine , WI 53403
Posted 1 week ago
About the Company:
Merz is a family-owned medical device and pharmaceutical company headquartered in Germany. Our Global Technical Operations based in WI manufactures, packages and ships several innovative products so that people all over the world can live better, feel better, and look better.
Key Responsibilities:
Change Control:
Support/Lead Change Control Activities (Operations, Engineering, Design, etc.). Support updates to operating procedures, process, product / specifications, risk management files, etc through the Change Control process.
Support/Lead 3rd party supplier management activities such as review 3rd party design control activities.
Support NCR and CAPA:
Design Control:
Risk Management:
Inspections:
Support/Lead with federal, state, and local regulatory officials during regulatory inspections.
Support/Lead in internal and vendor quality system audits as applicable.
Quality Initiatives:
Identifies and implements new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies.
Works with manufacturing and other functional groups on manufacturing regulatory compliance issue
Support/Lead training program by developing, coordinating, and delivering assigned training tasks.
Adherence to Regulations:
Management:
Other duties as assigned:
Education:
Sr. Quality Engineer
Quality Engineer
Experience:
Sr. Quality Engineer
Quality Engineer
Knowledge, Skills and Abilities:
Knowledge of Regulatory Requirements: Deep understanding of regulatory requirements for medical devices and pharmaceutical organizations. Familiar with ISO 13485, FDA Quality System Regulations, GMPs, and other international regulations.
Technical and Problem-Solving Skills: Strong technical and general problem-solving skills, with specific experience in NCR/CAPA processes.
Audit Experience: Proven ability to perform internal and/or supplier audits.
Risk Management and Standards: Knowledge of Medical Device Risk Management regulation ISO 14971 and understanding of IEC 62304.
Software and Integration Knowledge: Understanding of system software, firmware, and hardware integration.
Computer Skills: Proficient in Microsoft Office (Word, Excel, PowerPoint, Visio), Adobe, Access, and Quality System Management Software.
Communication Skills: Highly effective communication skills, capable of working with company staff and effectively communicating throughout the organizations.
Multitasking and Priority Management: Ability to manage multiple priorities and work with interruptions.
Independent and Decision-Making Skills: Capable of working with minimal supervision and making effective decisions for diverse and complex issues.
Benefits:
Comprehensive Medical, Dental, and Vision plans
20 days of Paid Time Off
15 paid holidays
Paid Sick Leave
Paid Parental Leave
401(k)
Employee bonuses
And more!
Your benefits and PTO start the date you're hired with no waiting period!
Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!
Merz Pharmaceuticals USA