Quality Engineer

Angel Aligner

Quality Engineer

Job Summary: The Quality Engineer ensures compliance of products and processes with the FDA QMSR 820 and ISO 13485 through performing inspections, conducting tests, and analyzing data, and providing support for manufacturing operations and quality functions. Bridging hands-on technical execution and engineering-level solutions, this role helps uphold product quality, process control, and the compliance of audits.

Essential Functions:

Performs incoming, in-process, and final inspections using calipers, micrometers, gauges, vision systems, or other metrology tools.
Responsible for daily product quality management on the production line, promptly addressing relative issues to ensure product and service with high quality, meet or exceed customer requirements.
Promptly handle customer feedback & complaints (includes but not limited to receiving, evaluation handling, response and trend analysis), and lead the analysis and resolution of internal customer complaint. When necessary, provide investigation results to HQ Post-market team within 24 hours
Technical support of Physical Products including problem solving & instruction for use.
Tracking new products/projects after sales; post-market problem identification and internal improvement motivation; post-market data collection and analysis; Promote the actions taken related to customer complaints.
Collaborate with HQ team to conduct FCA (field corrective action).
Manage and audit Class B suppliers (e.g., packaging materials); support HQ SQE teams in the management of Class A suppliers (key raw materials).
Develop inspection and control documents for product quality and provide job training and assessments for relevant employees.
Assist in implementing & maintenance quality management system and support audits, track improvement measures, actively use various quality improvement tools, and promote them extensively to facilitate improvements in quality control.
Track changes in various aspects' validation of the production line (new raw materials, new processes, new equipment) and ensure the continuous stability of products.
Track Non-Conformance Reports (NCR), Corrective and Preventive Actions (CAPA), and other anomalies.
Strictly adhere to company's relative regulations of information security and privacy.
Supports nonconformance investigations, including containment, defect analysis, and documentation.
Other duties as assigned.

Qualifications:

Associate or Bachelor's degree in Engineering, Quality, or related technical field (or equivalent experience).
Experience in a regulated manufacturing environment-medical device preferred.
Strong understanding of cGMP, ISO 13485, and QMSR 820.
Proficiency with measurement tools and inspection equipment.
Strong documentation, communication, and analytical skills.

Preferred but not required Qualifications:

Experience with CAPA, NCRs, and root-cause analysis tools.
Familiarity with statistical techniques (SPC, MSA, capability studies, sampling plans).
Experience with cleanroom manufacturing or sterile device processes.

Competencies:

Strong problem-solving and critical-thinking skills
High attention to detail and documentation accuracy
Ability to work cross-functionally in a fast-paced environment
Commitment to patient safety and product quality
Continuous improvement mindset

Physical and Work Environment Requirements:

Ability to work in office, lab, and manufacturing environments
Occasional travel for supplier audits or training
Ability to lift up to 40 lbs.

Travel & Benefits

Travel is approximately 5% with international overnight stays required
We offer a competitive base salary and benefits.

Apply

Vacancy posted 4 days ago

Similar jobs that could be interesting for youBased on the Quality Engineer in Oak Creek, WI vacancy

Quality Engineering Senior
$86k - $126k
Eaton’s Electrical Division is seeking a Sr. Quality Engineer . This role will be based at our South Milwaukee, Wisconsin facility. (Relocation is offered)The expected annual salary range for this role is $86000 - $126000 a year. Please note the salary information shown...
Suggested
H1b
Local area
Immediate start
Relocation
Visa sponsorship
Relocation package
Eaton Corporation
South Milwaukee, WI
2 days ago
Customer Quality Engineer
...Smart4Chemicals are looking to recruit a Customer Quality Engineer to join a leading global manufacturer within the coatings and materials sector, based at their Oak Creek, Wisconsin facility. This is a customer-facing quality role where you will take ownership of customer...
Suggested
Full time
Work at office
Smart4 Sciences
Oak Creek, WI
3 days ago
Customer Quality Engineer
As Customer Quality Engineer (CQE), you are responsible for ensuring customer quality requirements are met and for leading the resolution of customer quality issues across the product lifecycle. You serve as the primary quality liaison between customers and internal cross...
Suggested
Work at office
PPG Industries
Oak Creek, WI
4 days ago
Quality Engineer II
$45 - $60 per hour
...Job Description Job Description Job Description: Quality Engineer II This Quality Engineer II role focuses on driving robust quality processes within a fast-growing manufacturing environment that produces switchgear, busbars, and electrical distribution equipment...
Suggested
Contract work
Temporary work
Actalent
Cudahy, WI
3 days ago
Quality Engineer II
$45 - $60 per hour
...Job Description Job Description Job Title: Quality Engineer II Job Description This Quality Engineer II role focuses on driving robust quality processes within a fast-growing manufacturing environment that produces switchgear, busbars, and electrical distribution...
Suggested
Contract work
Temporary work
Actalent
Cudahy, WI
3 days ago
Process/Quality Engineering Intern
...Join our Oak Creek, WI team as a Quality Engineering Intern ! Our internships are hands on, highly technical, and designed to let you see what it's like to work at Astronautics. This is a paid undergraduate intern opportunity. As an engineering intern, you will work...
Full time
Part time
Summer work
Internship
Summer internship
Work at office
Astronautics
Oak Creek, WI
5 days ago
Quality Assurance Test Engineer
...Elwood is searching for a skilled and motivated Test/Controls Engineer with a firm background in supporting Quality Assurance and Quality Management Systems and a record of accomplishments to help make process improvements and take our operations to the next level....
Full time
Local area
Worldwide
Elwood Corporation
Racine, WI
4 days ago
Engineering - Quality Assurance Engineering/Control)
$72.57k - $101.92k
...is also eligible for S&C’s annual incentive plan (AIP), subject to eligibility criteria. Join Our Team as a Manufacturing Quality Engineer II ! Are you passionate about Quality Assurance? S&C Electric Company is seeking a dynamic individual to join our US QA...
Full time
Temporary work
Work at office
Local area
Worldwide
Flexible hours
S&C Electric Company
Franklin, WI
2 days ago
Quality Engineering (Assembly / Manufacturing)
...Description Position Overview The Quality Engineer develops, implements, and improves quality systems and processes for electrical power distribution equipment, including switchgear, control panels, and related assemblies. This role partners with Engineering, Manufacturing...
Full time
MPD INTEGRATION LLC
Cudahy, WI
2 days ago
Customer Quality Engineer
...to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding.As Customer Quality Engineer (CQE), you are responsible for ensuring customer quality requirements are met and for leading the resolution of customer quality...
Work at office
Adecco
Oak Creek, WI
5 days ago
Quality Engineer 1
...Job Description Job Description Position Summary The Quality Engineer I supports the development, implementation, maintenance, and continuous improvement of the company's Quality Management System (QMS) to ensure products meet customer requirements, regulatory...
Work at office
MPD Integration LLC
Cudahy, WI
23 days ago
Quality Engineer 2
...Job Description Job Description POSITION SUMMARY The Quality Engineer 2 is responsible for supporting and improving quality processes within an engineered-to-order electrical distribution products manufacturing environment. This position works cross-functionally...
Permanent employment
Work at office
MPD Integration LLC
Cudahy, WI
25 days ago
Associate, Quality Engineering
$59k - $86k
...Associate Quality Engineer Eaton's Electrical Division is currently seeking an Associate Quality Engineer to join our team. This position is based at our South Milwaukee, WI facility. The expected annual salary range for this role is $59000 - $86000 a year. Please...
H1b
Local area
Immediate start
Visa sponsorship
Relocation package
Eaton Plc
South Milwaukee, WI
5 days ago
Associate, Quality Engineering
$59k - $86k
...Eaton's Electrical Division is currently seeking an Associate Quality Engineer to join our team. This position based at our South Milwaukee, WI facility. The expected annual salary range for this role is $59000 - $86000 a year. Please note the salary information...
H1b
Local area
Immediate start
Visa sponsorship
Relocation package
Eaton
South Milwaukee, WI
3 days ago
Quality Engineering S
...life and making a living. Live your best life with Merz Aesthetics.A Brief OverviewThis position is responsible for providing Quality Engineering and Technical Support for operations, sustaining engineering, R&D, and New Product Introduction. This position would include...
Full time
Local area
Remote work
2 days per week
Merz Pharma
Racine, WI
4 days ago
Quality Engineering S
...of suppliers, in accordance with product risk profile. Primary Quality Contact for Merz to critical vendors. Merz is as responsible... ...directed by Quality Management.Minimum RequirementsBachelor of Engineering (B.E.) BS in a Physical Science or equivalent experience.Preferred...
Full time
Local area
Merz Pharma
Racine, WI
3 days ago
Quality Engineering S
...Quality Engineer Opportunity Are you looking for a new exciting career with a growing company focused on its employees and the environment? Are you a quality engineer who recently graduated or are you looking for a new opportunity? Seda North America may have an exciting...
Work at office
Local area
Monday to Friday
Flexible hours
Seda International Packaging Group SpA
Racine, WI
4 days ago
Supplier Quality Engineer
...Supplier Quality Engineer Global Power Components is seeking a dynamic individual to join our Quality Assurance department. As a Supplier Quality Engineer, you will be crucial in ensuring smooth operations with minimum/no Quality escape from suppliers by utilizing...
Work at office
Global Power Components
Caledonia, WI
3 days ago
Quality Engineering (Assembly / Manufacturing)
...Quality Engineer – Plant Operations For more than 100 years, Modine has solved the toughest thermal management challenges for mission-critical applications. Our purpose of Engineering a Cleaner, Healthier World™ means we are always evolving our portfolio of technologies...
Temporary work
Internship
Worldwide
Modine Manufacturing Company
Racine, WI
5 days ago
Quality Engineering S
...growth is exactly on plan. As they scale up and add new lines they continue to mature their operation and their team. The Quality Engineer will touch every aspect - suppliers, customers, team members, FMEA, documentation and more. Qualifications ~ BSME...
GUIDED SEARCH PARTNERS
Racine, WI
2 days ago
Manufacturing quality engineering
$87k - $133k
...ready to make an impact and build a career with purpose, there's a place for you at CNH. Job Purpose As the Supplier Quality Engineer for Metallic Commodity, you will lead quality activities, quality strategies and the relationships with key suppliers to ensure...
Full time
Work at office
Remote work
Home office
3 days per week
CNH Industrial N.V.
Racine, WI
4 days ago
Quality Engineering Senior
...WhirlpoolCorp.com . The team you will be a part of The Supplier Quality team lead, manage and monitor the performance, quality and... ...~5+ years of experience in a supplier or quality engineering role ~ Bachelors degree in Mechanical, electrical, quality or...
Work from home
Monday to Friday
Whirlpool Corporation
Racine, WI
4 days ago
Senior Quality Engineer
...Senior Quality Engineer Global Power Components is seeking an experienced Senior Quality Engineer to lead advanced quality initiatives, drive systemic improvements, and strengthen our manufacturing quality systems across multiple product lines. This role is ideal for...
Local area
Global Power Components
Caledonia, WI
3 days ago
Customer Quality Engineer
...Customer Quality Engineer At Modine, we are engineering a cleaner, healthier world. Building on more than 100 years of excellence in thermal management, we provide trusted systems and solutions that improve air quality and conserve natural resources. More than 13,0...
Temporary work
Modine Manufacturing Company
Racine, WI
5 days ago
Quality Engineer
...Job Description Job Description Description FII USA, Inc ., a Foxconn Technology Group Company, is seeking a Quality Engineer to ensure product quality standards and implement quality improvement initiatives. Once a part of the team, you will be responsible for...
Full time
Temporary work
Foxconn WI
Mount Pleasant, WI
28 days ago
Manufacturing Intern - Quality Engineering
...innovation and detail and ensure that each customer receives the best quality in product and service. We are currently looking for candidates... ...and work instructions Work closely with quality and process engineers on ISO 9001 compliance tasks, parts protection data collection,...
Internship
Worldwide
Flexible hours
Krones AG
Franklin, WI
2 days ago
Senior Manager Quality Engineering-Labeling
...Aesthetics.A Brief OverviewThis role is responsible for labeling quality and compliance activities to ensure product labeling meets... ...Minimum RequirementsBachelor of Science (B.S.) Life Sciences, Engineering, Regulatory Affairs, or related technical discipline5+ years Progressive...
Full time
H1b
Merz Pharma
Racine, WI
4 days ago
Manufacturing quality engineering
$72.57k - $101.92k
...is also eligible for S&C's annual incentive plan (AIP), subject to eligibility criteria. Join Our Team as a Manufacturing Quality Engineer II ! Are you passionate about Quality Assurance? S&C Electric Company is seeking a dynamic individual to join our US QA...
Temporary work
Work at office
Local area
Worldwide
Flexible hours
S&C
Franklin, WI
2 days ago
Mechanical Test Engineer
...Job Description Our client has an opportunity for an experienced Mechanical Test Engineer to join their Materials Testing team. This position offers a unique chance for you to apply, develop, and challenge your skills and abilities on a daily basis. You will work...
Work at office
SITE Staffing
Greendale, WI
1 day ago
Testing Systems Engineering
...Job Title: Systems Test Engineer Job Description: We are seeking Systems Test Engineers to provide comprehensive test coverage... ...agricultural product models or systems for performance, quality, and reliability testing. Operate and drive agricultural...
Kasmo Global
Racine, WI
3 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Quality Engineer. Be the first to apply!