- RequiredASQ Certification as a Quality Engineer or equivalent.
- PreferredBS Engineering.
- 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.
- Required2 years in a quality role.
- Preferred2 years working with electromechanical devices.
-
Technician, Quality Engineering
1 week ago
SC Johnson Racine, United StatesSC JOHNSON IS A FIFTH-GENERATION FAMILY COMPANY BUILT ON THE SPIRIT OF OUR PEOPLE. We have been leading with purpose for over 130 years, building iconic brands that win the hearts and minds of consumers - such as Raid, Glade, Ziploc and more, in virtually every country around the ...
-
Director Quality Engineering
1 week ago
Scientific Search Racine, United StatesDirector, Quality Engineering · Racine, Wisconsin · Hybrid Schedule · Are you looking for a professional home that truly values their team? Lots of time off and other perks? How about amazing bonus potential and the ability to grow? This job has it all · As the · Director of ...
-
Senior Quality Engineer
1 week ago
O&H Danish Bakery Racine, United StatesNonin Overview: You can count on Nonin. Our vision is to improve people's lives by creating noninvasive medical devices people can count on, even in challenging conditions. Nonin's culture is grounded in our mission and vision, and our values are reflected in our commitment to di ...
-
Quality Assurance Automation Engineer
4 days ago
Uline Racine, United StatesQuality Assurance Automation Engineer · Corporate Headquarters · 12575 Uline Drive, Pleasant Prairie, WI 53158 · Keep our growing company running smoothly and efficiently As Uline's Quality Assurance Automation Engineer, implement automated testing and tooling solutions for North ...
-
Quality Engineer
1 week ago
SEDA North America Sturtevant, United StatesJob Description · Job DescriptionAre you looking for a new exciting career with a growing Company focused on its Employees, and the Environment? Are you a Quality Engineer looking for a new opportunity? Seda North America may have an exciting opportunity for you · Seda North Ame ...
-
Quality Engineer
2 days ago
SEDA NORTH AMERICA INC. Sturtevant, United StatesAre you looking for a new exciting career with a growing Company focused on its Employees, and the Environment? Are you a Quality Engineer looking for a new opportunity? Seda North America may have an exciting opportunity for you · Seda North America, recently certified as a Gre ...
-
Quality Engineer
4 hours ago
Techstaff Sturtevant, United StatesTechstaff is seeking a Production Quality Engineer for our client in the Milwaukee area. This position will focus Process Capability, non- conformance, corrective actions and working closely with Internal and external customers to solve production and design problems. **APQP and ...
-
Quality Engineer
3 days ago
Foxconn Industrial Internet Sturtevant, United StatesJob Description · Job DescriptionFoxconn is seeking for a Quality Engineer that performs reviews of all PCBA, Mechanical and System Level factory yield and failure analysis data provided by the Manufacturing Quality engineers and Failure analysis technicians. This position identi ...
-
Quality Engineer
4 days ago
Foxconn Industrial Internet Sturtevant, United StatesFoxconn is seeking for a · Quality Engineer · that performs reviews of all PCBA, Mechanical and System Level factory yield and failure analysis data provided by the Manufacturing Quality engineers and Failure analysis technicians. This position identifies trend items and drives ...
-
Quality Engineer
1 week ago
Foxconn Industrial Internet Sturtevant, United StatesJob Description · Job Description · Foxconn is seeking for a · Quality Engineer · that performs reviews of all PCBA, Mechanical and System Level factory yield and failure analysis data provided by the Manufacturing Quality engineers and Failure analysis technicians. This posi ...
-
Quality Engineer
6 days ago
Techstaff Sturtevant, United StatesDetails: Techstaff is seeking a Production Quality Engineer for our client in the Milwaukee area. This position will focus Process Capability, non- conformance, corrective actions and working closely with Internal and external customers to solve production and design problems. ** ...
-
Senior Quality Engineer
1 week ago
Penn Foster Inc Wind Point, United StatesSenior Quality Engineer · Racine, Wisconsin - Direct Hire · Productive Resources ) is seeking a candidate to be part of our customer's team at their facility in Racine, Wisconsin. You will perform activities related to quality including planning and implementation of the company ...
-
Sr. Quality Engineer, Business Technology
6 days ago
Merz North America Racine, United StatesAbout the Company:Family owned since 1908 Merz Aesthetics is the world's largest dedicated medical aesthetics business. Choose Merz Aesthetics because it is unique - unique in our relationships with customers, in our products and in the way we treat each other.As Sr. Quality Engi ...
-
Merz North America Racine, United StatesAbout the Company: · Family owned since 1908 Merz Aesthetics is the world's largest dedicated medical aesthetics business. Choose Merz Aesthetics because it is unique - unique in our relationships with customers, in our products and in the way we treat each other. · As Sr. Qual ...
-
Quality Engineer
1 week ago
Foxconn Industrial Internet Franksville, United StatesFoxconn is seeking for a Quality Engineer that performs reviews of all PCBA, Mechanical and System Level factory yield and failure analysis data provided by the Manufacturing Quality engineers and Failure analysis technicians. This position identifies trend items and drives root ...
-
Quality Engineer
1 day ago
Foxconn Industrial Internet Franksville, United StatesFoxconn is seeking for a Quality Engineer that performs reviews of all PCBA, Mechanical and System Level factory yield and failure analysis data provided by the Manufacturing Quality engineers and Failure analysis technicians. This position identifies trend items and drives root ...
-
Quality Engineer Associate
1 week ago
The Accuro Group Sturtevant, United StatesBusiness Title: 2819 | Quality Engineer AssociateLocation 1: Sturtevant, WI 53177Location 2: Franksville, WI 53126Job Type: Contract (3 months and 17 days) · Job Description: · As an Entry Level Quality Engineer Associate, you will be an integral part of our quality assurance t ...
-
Quality Material Engineer
2 weeks ago
SEDA NORTH AMERICA INC. Sturtevant, United StatesJob Description · Job Description · Seda North America is looking for an on-site Quality Materials Engineer · to support manufacturing operations as an analytical driven lab technician who will be responsible for supporting our laboratory activities, incoming inspection, and s ...
-
QA Technician
2 days ago
Actalent Racine, United States Full timeDescription: · The QA Technician will be responsible for testing product samples from Production and Incoming Materials as well as ensuring HACCP/quality/GMP regulations are being followed accurately. Running lab tests including GC and LC testing. Will also complete floor tests i ...
-
Commodity Manager
3 days ago
Modine Manufacturing Company Racine, United StatesPosition Description · Reporting to the Director, Global Procurement, this role is an important member of the Air-Cooled Applications team as we develop our supplier and customer partnerships to define the future of cooling. · The Commodity Manager leads supplier development, par ...
Quality Engineer/ Sr. Quality Engineer - Racine, United States - Merz North America
Description
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:
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 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
Benefits:
Comprehensive Medical, Dental, and Vision plans20 days of Paid Time Off15 paid holidaysPaid Sick LeavePaid Parental Leave401(k)Employee bonusesAnd 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 contractor's legal duty to furnish information.
41 CFR c)