QA Regulatory and Safety Manager

Description

NorDx

Professional - Nonclinical
Req #: 99360

Summary:
The QA Regulatory and Safety Manager role coordinates and provides guidance for NorDx's Quality Program and manages regulatory affairs and safety activities. This role interacts with federal, state and professional regulatory agencies as required.

Required Minimum Knowledge, Skills, and Abilities (KSAs)

1. Education: Bachelor's Degree in Medical Technology or equivalent science required. Master's degree in business or healthcare preferred.
2. License/Certifications: Current certification as a technologist/technician by a recognized professional organization (e.g., ASCP, BOR, NCA) required. Certification as a specialist (e.g., SBB, SH, SM, SI), or a clinical laboratory leader preferred.
3. Experience: Five years of progressive clinical laboratory experience required. Experience in safety, quality assurance and regulatory preferred.
4. Additional Skills/Requirements Required: May be asked to work at other sites/locations as needed.
5. Additional Skills/Requirements Preferred: Basic computer skills

Additional Information

MaineHealth is committed to fostering a supportive, inclusive environment where care team members can thrive while making a meaningful impact in the communities we serve across Maine and New Hampshire. We offer competitive benefits including paid parental leave, flexible work options, student loan assistance, professional development opportunities, and well-being resources-so you can grow your career while feeling supported both personally and professionally.

We recognize the value each team member brings to our organization.Any offer of employmentwill depend onqualificationssuch asskills, relevant experience, education, certifications,and otherjob-relatedfactors. Thebase rangeis an estimate and does notreflect the full valueofourtotal compensationpackage.

The pay range for this position is $83,324.80to $112,736.00per year.

Compensation for part-time positions isdeterminedon a prorated basis consistent with the scheduled hours and applicable full-time equivalent (FTE).

In addition to base pay, MaineHealth offerscomprehensivebenefits, recognition programs, career growth opportunities, and,where applicable,shiftdifferentials or other incentives.

If you have questions about this role, please contact aarin.miles@mainehealth.org

Hiring Scam Alert

MaineHealth will never request financial information during the interview or pre-hiring process. All legitimate communications will come from an email address ending in @mainehealth.org. If you suspect fraudulent activity, please report it immediately to mhcareers@mainehealth.org.

Notice Regarding Maine Employer Surveillance Statute:Pursuant to Maine's Employer Surveillance Statute, prospective care team members are notified that MaineHealth may monitor, collect, record, review, or retain information related to the use of its systems, networks, applications, files, data, communications platforms (including notified recordings), smart badges, building access, company vehicle GPS data, business calls, and workplace security cameras.

Information collected may be used for legitimate business purposes, including security, safety, compliance, investigations, training, quality assurance, and operational management.