Quality Assurance Manager

PRIMARY FUNCTION

Responsible for implementing and performing quality system processes that ensure Endogenex meets requirements of internal procedures and applicable external standards / regulations (including but not limited to ISO 13485, 21 CFR 820,806 and 803, EU MDR, MDSAP).

PREFERRED QUALIFICATIONS

• Bachelor's degree with 7+ years of quality experience in medical device and / or comparable regulated environment
• Familiarity with applicable external standards / regulations (ISO 13485, USA, EU MDR, MDSAP, UK and Australian)
• Strong interpersonal, organizational, and technical writing skills
• Strong communication and leadership skills, with the ability to work effectively in a fast-paced, collaborative environment.
• Ability to manage multiple priorities with commitment and performance to deadlines
• Experience with implementing and completing activities that maintain compliance with document control requirementsand quality system management software systems (experience with Grand Avenue preferred)
• Experience implementing and completing activities related to Post Market Surveillance, Complaints, CAPAs, andNonconformances along with corresponding risk management determinations
• Strong computer skills and statistical trending techniques

RESPONSIBILITIES :

Implement and maintain document control and assigned portions of the quality system in compliance with applicable regulations and standards.

Processing document change requests, including reviewing for completeness, managing approvals, releasing documents, and managing document control assigned tasks following document release.

Responsible for all manufacturing and quality system trending and post-market surveillance activities.

Responsible for generating and managing all NCM and Servicing files .

Performs all quality system metric recording and report records.

Tracking and trending CAPAs, nonconformances, complaints and other quality system monitoring.

Implements complaint investigation process, including but not limited to complaint file documentation, departmental coordination, proper escalation, and initial reporting assessments.

Appropriately identifies outputs from work processes which drive additional efforts within the product lifecycle including but not limited to risk management updates, management review recommendations and quality system alert / alarm levels.

Manage calibrated equipment, including tracking when calibration is due, coordinating completion of calibration, and reviewing calibration certificates for accuracy without impacting production or R&D programs.

Manage employee training files and training program, ensuring employees stay up to date with required training. Lead efforts in streamlining and incorporating training material updates as required.

Manage creation, implementation, and ongoing monitoring of supplier and part approvals

Manage return material authorization (RMA) process.

Assist in preparation of management review presentations.

Tracking release of and coordination with affected department for implementation of new standards. Provide gap analysis assessment reports to affected departments.

Performs product dispositioning documentation on behalf of quality and execute quality assurance in return / service / rework programs - This includes responsibility for certificates of conformance approvals and finished goods inspection and lot release.

Performs all device related inspection procedures requiring quality oversight and approval

Supports production quality documentation retention for finished goods

Perform other duties and responsibilities as assigned.

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

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