Quality System Specialist II

Manpower Engineering is partnering with a leader in the medical device industry for a Quality Systems Specialist II.

Job Title: Quality Systems Specialist II

Location: Maple Grove, MN

Pay: $35 - $38/hr

Duration:

4 month contract through June/July 2025

POSITION SUMMARY :

Support multiple functions through maintaining and improving an effective and compliant quality system.

PRINCIPAL RESPONSIBILITIES :

Manage assigned portions of the quality system to ensure overall system effectiveness.

Provide training and mentorship to NCE and CAPA owners

Identify opportunities to continuously improve the quality system processes.

Responsible for identifying, implementing, and reporting metrics to site leadership

Ensure processes needed for the NCE and CAPA system are documented and controlled.

Maintain effective, efficient, and cohesive quality system processes which ensure compliance with internal requirements, as well as external (FDA, ISO, etc.) requirements and expectations.

Develop, implement, and maintain meaningful NCE/CAPA metrics to measure the quality system performance.

Supports organization and facilitation (front and back room) of FDA and Notified Body audits and inspections.

Support Management Review activities.

Perform internal audits per schedule.

Partners with Regulatory and/or departments to execute compliance-related strategies.

Partners with technical teams to ensure quality system enables success while maintaining compliance.

Initiate, prioritize, and lead optimization opportunities to increase effectiveness and efficiency.

Implement corporate strategic initiatives and execute at a site level.

EDUCATION / EXPERIENCE REQUIREMENTS : Minimum level of education/experience required.

Bachelor's Degree required

One to three years of relevant experience required

Preferred to have CQA or equivalent ISO 13485 trained

SPECIALIZED SKILLS & OTHER REQUIREMENTS :

Ability to lead cross-functional teams for project execution.

Audit experience preferred

Effective verbal and written communication.

Proficient in technical / systems writing and review.

Possess interpersonal skills to work in a team and as an individual contributor.

Ability to collaborate with personnel at all levels both within and outside the company.

Structured and methodical problem-solving approach.

Understanding of medical device industry quality system design and management.

Experience with FDA Quality Systems Regulations, ISO 13485, Quality Certificates, GMP, MDSAP, and EU MDR

Benefits:

Upon completion of waiting period consultants are eligible for:

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Health Flexible Spending Account

Dependent Care Flexible Spending Account

Supplemental Life Insurance

Short Term and Long-Term Disability Insurance

Accrued Sick Pay

401(k)

If this is a role that interests you and you?d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of Experis

ManpowerGroup (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands

Manpower, Experis, Talent Solutions, and Jefferson Wells


creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.