Job Description

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

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