Quality Systems Specialist

Job Title: Quality Systems Specialist

Location: Columbia Heights, MN
Duration: 12+months (Possibility of extension)

POSITION DESCRIPTION:

·This position has primary responsibility for supporting and providing oversight of the Neuromodulation Quality Management System.

·This position is responsible for ensuring the existing system is implemented and followed and will also be instrumental in improving the quality system as applicable.

·This role will lead quality system projects, audit readiness activities, improvements or initiatives and collaborate with site manufacturing and operations teams.

POSITION RESPONSIBILITIES:

·Ensure the Neuromodulation quality system is implemented, followed and the site maintains adherence to all quality policies, processes and procedures.

·Evaluate, develop, update and maintain quality policies and procedures in accordance with industry standards and regulations, with Healthcare Corporate policies and best practices.

·Provide quality expertise and guidance to the site personnel on quality system policies and procedures.

·Coach site staff to ensure a thorough understanding and effective implementation of quality policies and procedures.

·Serves as a liaison between Neuromodulation and various auditing agencies.

·Works directly with operations personnel to ensure compliance to specifications and requirements.

·Performs self-audits and will develop action plans for improving compliance from the self-audit results.

·Perform audit readiness activities by evaluating documentation, records and ensuring personnel are audit ready.

·Identify, lead or manage quality system improvements.

·Improvements to focus on effectiveness, efficiency and when applicable drive simplification.

·Provide support to the department and site as needed during audits and inspections.

BASIC QUALIFICATIONS:

·4-7 years of experience with a Bachelor’s degree OR

·2-5 years of experience with a Master’s degree

·Previous Quality System or auditing experience

·Previous medical device or other regulated industry experience

EDUCATION REQUIRED: (No equivalencies)
• Bachelor's degree in science or engineering

DESIRED/PREFERRED QUALIFICATIONS (optional):

·Experience in or support of manufacturing operations.

·Change control documentation systems (e.g. Agile, Enovia or Documentum

·CAPA documentation systems experience (e.g. Trackwise)

·Experience in both pharma and device product organizations.

·Knowledge of all aspects of medical device operations (quality, manufacturing, supply change, design).

·Bachelor’s degree in science or engineering

·ASQ certification as CQM, CQE, CQA

·Experience revising and improving an existing quality management system

·Working knowledge of Quality System Regulation (21CFR820), ISO 13485:2003, and CFR Parts 210 and 211.

·Solid judgment and problem solving skills

·Ability to manage multiple projects or priorities

·Strong influence and negotiation skills

PHYSICAL JOB REQUIREMENTS

·The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.

·Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions