Quality Engineer/ Sr. Quality Engineer

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Quality Engineer / Sr. Quality Engineer

Location : Racine, WI, USA

Category : Clinical / Medical / Regulatory Affairs

Job Id : QUALI003779

Job Type : Full Time

Posted Date : 08 / 28 / 2024

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.

This position is responsible for providing Quality Engineering and Technical Support for operations, sustaining engineering, R&D, and New Product Introduction.

This position would include supporting a wide array of activities related to Change Control, NCR / CAPA, Quality operations, Design Control, New Product Development, Risk Management and Post Market Surveillance.

This position would evaluate the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are needed.

Provide direct support to Quality personnel regarding operation of the department and Quality System. Provide support to other departmental activities as directed.

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 :

Support / lead corrective / preventive actions and product non-conformance including capturing data and investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.

Design Control :

Support operations, sustaining engineer, R&D and NPI departments in the development, verification and validation of product changes and introduction of new products.

Risk Management :

Support / Lead Risk Management activities including review and coordination of quality activities related to risk.

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 issues.
• Support / Lead training program by developing, coordinating, and delivering assigned training tasks.

Adherence to Regulations :

Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of Electromechanical Devices (EMD) and non-EMD medical devices.

Management :

For those who manage or supervise staff : Manage staff including interviewing, hiring, training, and developing employees;

planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Other duties as assigned :

Provides support to Quality Management personnel and perform other duties as assigned.

Education : Sr. Quality Engineer

Sr. Quality Engineer

• BS in a Physical Science or Engineering, or equivalent experience. Required
• ASQ Certification as a Quality Engineer or equivalent. Preferred
• BS Engineering. Preferred

Quality Engineer

BS in Engineering or equivalent experience. Required

Experience : Sr. Quality Engineer

Sr. Quality Engineer

• 5 years’ work experience at least 3 years in Quality in Medical Device. Required
• Experience with electromechanical device software and hardware validation. Preferred

Quality Engineer

• 2 years in Medical Device or similar experience. Required
• 2 years in a quality role. Preferred
• 2 years working with electromechanical devices. Preferred
• ASQ Certification as a Quality Engineer or equivalent. Preferred

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.

• 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.
• Familiar with ISO 13485 Quality System Standards, ISO 14971, FDA Quality System Regulations, GMPs, and / or other international medical device regulations.
• Understanding of IEC 60601, 62304, RoHS, WEEE.
• Understanding of system software, firmware, and hardware integration.
• 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!

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