Job Description

PRIMARY FUNCTION

Endogenex is seeking an experienced

Quality Manager

to lead and execute critical

Quality System (QMS)

activities in compliance with

ISO 13485

,

21 CFR 820

,

21 CFR 803/806

,

EU MDR

, and

MDSAP

requirements. This role is responsible for implementing, maintaining, and continuously improving quality system processes to support product development, manufacturing, and post-market activities.

PREFERRED QUALIFICATIONS

Bachelor's degree with

7+ years of Quality Management experience

in medical devices or a comparable regulated environment Hands-on familiarity with

ISO 13485

US

,

EU MDR

, and

MDSAP

(U.S., EU, UK, Australia) Strong technical writing, documentation, organizational, and communication skills Effective leadership in a fast-paced, cross-functional environment Experience with

Document Control

,

Change Control

, and

Quality Management System (QMS) software

(Grand Avenue preferred) Experience supporting

Post-Market Surveillance

,

Complaints

,

CAPA

, and

Nonconformances

, including risk management documentation Solid computer skills with demonstrated use of

statistical trending techniques

RESPONSIBILITIES:

Implement and maintain

Document Control

and assigned QMS processes in compliance with applicable regulations and standards Process and manage

Document Change Requests (DCRs)

, approvals, and document releases Lead

post-market surveillance

, manufacturing quality trending, and quality metric reporting Generate and maintain

NCM

and

Servicing

files Track and trend

CAPAs

,

Nonconformances

,

Complaints

, and other QMS monitoring data Implement and document

complaint investigations

, escalation, and initial reportability assessments Identify and communicate QMS outputs requiring action (risk management updates, management review inputs, alert levels, etc.) Manage

calibration programs

, including scheduling, certificate review, and coordination to avoid production impact Maintain

employee training records

and manage training program updates Manage

supplier and part approvals

and ongoing supplier quality oversight Oversee

RMA

processing and documentation Contribute to

Management Review

preparation and reporting Track and coordinate adoption of new or revised regulatory standards; perform

gap assessments

Execute

product disposition

, finished goods inspection, and lot release documentation Support quality documentation retention and production quality records Perform device inspections requiring Quality oversight Other duties as assigned

Job Type:

Full-time

Pay:

$90,000 - $120,000 per year

Benefits:

401(k) Health insurance Dental insurance Paid time off

Special Physical Demands and Working Conditions

1) Physical demands: While performing the duties of this job, the employee is occasionally required to walk; sit; use hands to finger, handle or feel objects, tools, or controls; reach with hands and arms; balance; stoop; talk and hear. Specific vision abilities required by the job include close vision and distance vision. Ability to occasionally lift and/or move up to 35 pounds.

2) Work environment: Fast paced work environment. While performing the duties of this job, the employee will experience in/out of the office noise at a minimal level. Must be capable of transporting self to various business locations. If using your own motor vehicle, must have a current, valid state driver's license and proof of insurance coverage that at least meets current residence's state minimum requirements. US and OUS travel may be required.

Job Type: Full-time

Pay: $90,000.00 - $120,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off
Application Question(s):

Do you live within driving distance of Plymouth, MN, zipcode 55441?
Education:

Bachelor's (Required)
Experience:

Quality systems: 5 years (Required)
Work Location: In person