Quality Systems Specialist

Integrated Resources Inc.; Columbia Heights (MN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Referral bonus of $500

Job summary

A premier staffing firm is seeking a Quality Systems Specialist in Columbia Heights, MN. This role involves oversight of the Neuromodulation Quality Management System, leading quality initiatives, and ensuring compliance with industry standards. Candidates should have substantial experience in quality systems, with a Bachelor’s or Master’s degree. The position offers significant responsibilities in a collaborative environment focused on quality improvement.

Qualifications

• 4-7 years of experience with a Bachelor’s degree or 2-5 years of experience with a Master’s degree.
• Previous experience in a quality system or auditing within a regulated industry.
• Knowledge of QSR (21CFR820), ISO 13485:2003 fundamentals.

Responsibilities

• Support and oversee the Neuromodulation Quality Management System.
• Lead quality system projects and ensure adherence to quality policies.
• Conduct self-audits and develop compliance improvement plans.

Skills

Quality System

Auditing

Problem Solving

Negotiation

Influence

Education

Bachelor's degree in science or engineering

Tools

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

CAPA documentation systems (e.g. Trackwise)

Job description

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

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

Additional Information

We do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job.

Thanks & Regards,
Seema Chawhan
Clinical Recruiter
Integrated Resources , Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE | GSA - Schedule 66 I GSA - Schedule 621I
DIRECT # - 732-844-8724

LinkedIn: https://in.linkedin.com/in/seemachawhan
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