- RequiredASQ Certification as a Quality Engineer or equivalent.
- PreferredQuality EngineerBS in a Physical Science or Engineering, or equivalent experience.
- RequiredASQ Certification as a Quality Engineer or equivalent
- PreferredExperience:Sr.
- RequiredExperience with electromechanical device software and hardware validation.
- PreferredQuality Engineer2 years in Medical Device or Pharmaceutical industry or similar experience.
Quality Engineer/ Sr. Quality Engineer - Racine, United States - Merz North America
Description
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:
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.
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 issueSupport/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 assignedEducation:Sr. Quality EngineerBS in a Physical Science or Engineering, or equivalent experience.
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.
Comprehensive Medical, Dental, and Vision plans20 days of Paid Time Off15 paid holidays401(k)And moreYour benefits and PTO start the date you're hired with no waiting periodCome join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employeesEqual Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe 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 contractors legal duty to furnish information.
41 CFR c)#J-18808-Ljbffr