Top 16 Quality assurance specialist Jobs in Milwaukee Wi

Regulatory Affairs & Quality Systems Specialist
Ontech Talent —Pewaukee, WI
- $70,000 - $99,000 a year
- Full-time
- 5 years
- Engineering
- Office
- Health insurance
- Dental insurance
Quick Apply
Customer Quality Excellence Specialist - Germantown, WI
dsm-firmenich —Germantown, WI
- Monday to Friday
- English
- Bachelor's degree
- Continuous improvement
- Health insurance
- Paid time off
Quality Systems Specialist
MPE-Inc —Milwaukee, WI
- $75,000 - $85,000 a year
- Full-time
- Mid-level
- Office
- Business Administration
- Profit sharing
- Paid training
Quick Apply
LAB QUALITY SPECIALIST, WDL; FULL TIME - 1ST SHIFT
Wisconsin Diagnostic Laboratories —Milwaukee, WI
- Full-time
- Mid-level
- 3 years
- Analysis skills
- Continuing education credits
- Disability insurance
Sr. Associate Specialist, Product Surveillance, Clinical WHXR
GE HEALTHCARE —Waukesha, WI
- Pass drug screening
- Mid-level
- High school diploma or GED
- Relocation assistance
- Health insurance
7d
Quality Specialist
AW Lake Company —Oak Creek, WI
- Mid-level
- Analysis skills
- Math
- Health savings account
- Paid holidays
Quick Apply
Clinical Research Quality Assurance Specialist II - Cancer Center
The Medical College of Wisconsin, Inc. —Milwaukee, WI
- Full-time
- Writing skills
- Mid-level
- University
- Paid parental leave
- Paid holidays
Quick Apply
Quality Management Systems Specialist
ATI —Cudahy, WI
- Computer literacy
- Mid-level
- 3 years
Quick Apply
Quality Control Specialist
Terex Corporation —Waukesha, WI
- $27 - $33 an hour
- Full-time
- Engineering
- Mentoring
- Welding
- Health insurance
- Dental insurance
Quality Systems Specialist
MGS Mfg. Group, Inc —Richfield, WI
- Full-time
- Mid-level
- 3 years
- High school diploma or GED
- Disability insurance
- Health insurance
Quick Apply
Regulatory Specialist
A L SCHUTZMAN COMPANY —Waukesha, WI
- Full-time
- Mid-level
Quality Floor Specialist (Nights)
Sterling Pharma Solutions —Germantown, WI
- 12 hour shift
- Microsoft Excel
- Microsoft Outlook
- Writing skills
Food Safety and Quality Specialist, Senior
Malteurop North America —West Allis, WI
- Full-time
- 5 years
- Analysis skills
- Bachelor's degree
Quick Apply
QA Specialist
CSL Centro Sperimentale Del Latte USA Inc —Franksville, WI
- Full-time
- Microsoft Excel
- Customer service
- Bachelor's degree
Quick Apply
4d
Commercial Nuclear Quality Assurance Specialist
Johnson Service Group Inc. —United States
- Up to $100 an hour
- Contract
- Remote
- 5 years
- Bachelor of Science
- Travel
- Disability insurance
- Health insurance
Quick Apply

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Regulatory Affairs & Quality Systems Specialist

Ontech Talent
Pewaukee, WI

Quick Apply

Job Details

Full-time
$70,000 - $99,000 a year

Benefits

Health insurance
Dental insurance
401(k)
Paid time off
Vision insurance
401(k) matching
Life insurance

Qualifications

FDA submissions
Medical software
Medical device testing
ISO standards
Engineering
Process improvement
DICOM
Bachelor's degree
Quality improvement
Regulatory affairs
Regulatory submission editing and review
Design controls
Biomedical regulatory compliance
Quality audits

Full Job Description

Title: Regulatory Affairs & Quality Systems Specialist

Location: Pewaukee, WI (On-Site)

Job Summary:

The incumbent is responsible for advancing regulatory and quality strategy for its cardiac imaging Software as a Medical Device (SaMD) portfolio. This role provides hands-on support for U.S. FDA and international regulatory compliance, ensures the effectiveness of the Quality Management System (QMS), and supports product development and lifecycle activities in a highly regulated environment.

Key Responsibilities & Duties:

Supports U.S. FDA submissions, primarily 510(k), including preparation and maintenance of Design History Files (DHF), Device Master Records (DMR), and associated technical documentation.
Provides input into regulatory strategies for varying markets (i.e. U.S., EU (MDR), and UKCA ).
Provides regulatory guidance on intended use statements, performance claims, labeling, and promotional considerations.
Monitors and assesses changes to applicable regulations, guidance documents, and standards; proactively communicates impact and recommendations.
Supports the Quality Management System (QMS), encompassing CAPA, complaint handling, post-market surveillance, vigilance reporting, internal audits, and ongoing quality improvements.
Ensures compliance with applicable standards, including IEC 62304 (software lifecycle), ISO 14971 (risk management), and IEC 62366 (usability engineering).
Supports software releases by performing regulatory impact assessments, change evaluations, and documentation updates.
Provides regulatory and quality input as it relates to cybersecurity risk management, field actions, and corrective actions, as applicable.
Executes core duties and responsibilities of the role in accordance with the established skills competencies.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

The above list reflects the general details necessary to describe the principle and essential functions of the position and shall not be construed as the only duties that may be assigned for the position.

Education & Qualifications:

Bachelor’s degree in a relevant technical, engineering, or life sciences discipline.
Minimum of 5 years of experience in Regulatory Affairs and/or Quality Systems within the medical device or SaMD industry.
Demonstrated hands-on experience leading FDA 510(k) submissions.
Established working knowledge of FDA QMSR, ISO 13485, IEC 62304, ISO 14971, and related regulatory requirements.
Strong regulatory judgment and ability to apply regulations pragmatically in a fast-paced development environment.
Excellent written and verbal communication skills, including the ability to interface with regulators and internal stakeholders.
Ability to work independently, prioritize effectively, and make sound, proactive decisions.

Preferred Qualifications:

Proven success working in cross-functional, matrixed organizations.
Experience with cardiac imaging, radiology software, or diagnostic imaging systems.
Direct experience with SaMD and Medical Device Software (MDSW).
Hands-on experience preparing EU MDR technical documentation.
Familiarity with DICOM standards and cardiac clinical workflows.

Physical Demands & Work Environment:

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical demands: While performing duties of job, employee is frequently required to type, sit, stand; walk; use hands, talk and hear; occasionally reach with hands and arms. Employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
Work Environment: The noise level in the work environment is minimal.

Equal Opportunity Employer: We are proud to foster an inclusive and diverse workplace culture. We are an equal opportunity employer and are committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetics, or any other characteristic protected by applicable federal, state, or local law. We value diversity and believe that a diverse and inclusive workforce is essential to drive innovation, foster creativity, and achieve success. We welcome and encourage applications from individuals of all backgrounds and are dedicated to ensuring a fair and equitable recruitment and employment process for everyone.

Job Type: Full-time

Pay: $70,000.00 - $99,000.00 per year

Benefits:

401(k)
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance

Application Question(s):

Will you now or in the future require work visa sponsorship?

Education:

Bachelor's (Required)

Experience:

Regulatory Affairs and/or Quality Systems : 5 years (Required)
medical device or SaMD industry: 5 years (Required)

Ability to Commute:

Pewaukee, WI 53072 (Required)

Work Location: In person

Quick Apply

Refine Your Search

quality assurance specialist jobs in milwaukee wi

Regulatory Affairs & Quality Systems Specialist

Customer Quality Excellence Specialist - Germantown, WI

Quality Systems Specialist

LAB QUALITY SPECIALIST, WDL; FULL TIME - 1ST SHIFT

Sr. Associate Specialist, Product Surveillance, Clinical WHXR

Quality Specialist

Clinical Research Quality Assurance Specialist II - Cancer Center

Quality Management Systems Specialist

Quality Control Specialist

Quality Systems Specialist

Regulatory Specialist

Quality Floor Specialist (Nights)

Food Safety and Quality Specialist, Senior

QA Specialist

Commercial Nuclear Quality Assurance Specialist

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