Quality Assurance Specialist

3 days ago

Racine, Wisconsin, United States Merz North America Full time
About the Company

Merz North America is a leading medical device and pharmaceutical company headquartered in Germany. Our Global Technical Operations based in WI manufactures, packages and ships innovative products to improve the lives of people worldwide.

Job Summary

We are seeking a highly skilled Quality Engineer/Senior Quality Engineer to provide Quality Engineering and Technical Support for operations, sustaining engineering, R&D, and New Product Introduction. This role involves supporting a wide range of activities related to Change Control, NCR/CAPA, Quality operations, Design Control, New Product Development, Risk Management, and Post Market Surveillance.

Key Responsibilities:
  • 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
  • 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
Requirements:
  • 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. 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
  • Knowledge of regulatory requirements for medical device/pharmaceutical organization
  • 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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

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