Quality Investigations Engineer (Biotech)
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 NCR and CAPA activities. 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:
Quality initiatives
• Identify 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 training program by delivering assigned training tasks.
NCR and CAPA
• Support / lead corrective/preventive actions and product non-conformance including capturing data and investigations associated with product deviations, product non-conformances (NCR), CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
• Conduct CAPA and NCR review and approvals.
• Run the Material Review Board (MRB).
Adherence to regulations
• Assist with adherence to all Federal, State and Local Regulations controlling the manufacture medical devices, cosmetics, and pharmaceuticals.
Inspections
• Support with federal, state, and local regulatory officials during regulatory inspections.
Other duties as assigned
• Provides support to Quality Management personnel and perform other duties as assigned.
Education:
• BS in Engineering or equivalent experience. Required
Experience:
• 2 years in Medical Device or similar experience. Required
• 2 years in a quality role. Preferred
• ASQ Certification as a Quality Engineer or equivalent. Preferred
Knowledge Skills and Abilities:
• Knowledge of regulatory requirements for medical device / pharmaceutical organization.
• Strong technical and general problem-solving skills required; experience with NCR/CAPA processes.
• Computer skills in Microsoft Word, Excel, PowerPoint, Visio and Access; Adobe; and Quality System Management Software.
• Familiar with ISO 13485 Quality System Standards, ISO 14971, FDA Quality System Regulations, GMPs, and/or other international medical device regulations
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)
Quality Assurance Engineering
