QA Regulatory and Safety Manager

MaineHealth; Scarborough (ME); On-site; USD 83,000 - 113,000; Full time

Benefits offered by this job

Paid parental leave

Flexible work options

Student loan assistance

Professional development opportunities

Well-being resources

Job summary

MaineHealth seeks a QA Regulatory and Safety Manager in Scarborough, ME to coordinate the Quality Program and manage regulatory affairs and safety activities. The role interacts with federal, state and professional regulatory agencies as required.

Ideal candidates hold a Bachelor's in Medical Technology or related science, current technologist/technician certification, and at least five years of clinical laboratory experience, with a strong background in safety and QA.

Qualifications

• Bachelor's Degree in Medical Technology or equivalent science is required.
• Certification as a technologist/technician by a recognized professional organization is required.
• Five years of progressive clinical laboratory experience is required.
• Experience in safety, quality assurance and regulatory is preferred.

Responsibilities

• Coordinates and provides guidance for the Quality Program and manages regulatory affairs and safety activities.
• Interacts with federal, state and professional regulatory agencies as required.
• May be asked to work at other sites/locations as needed.

Skills

Basic computer skills

Education

Bachelor's Degree in Medical Technology or equivalent science

Master's degree in business or healthcare (preferred)

Certification as technologist/technician (e.g., ASCP, BOR, NCA)

Specialist certification or clinical laboratory leadership (preferred)

Job description

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)

• Education: Bachelor's Degree in Medical Technology or equivalent science required. Master's degree in business or healthcare preferred.
• 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.
• Experience: Five years of progressive clinical laboratory experience required. Experience in safety, quality assurance and regulatory preferred.
• Additional Skills/Requirements Required: May be asked to work at other sites/locations as needed.
• 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.

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.