Quality Assurance Compliance Coordinator

Position: QUALITY ASSURANCE COMPLIANCE COORDINATOR
QUALITY ASSURANCE COMPLIANCE COORDINATOR

Pay Competitive

Location East Hartford/Connecticut

Employment type

Other

Job Description

• Req#: 37635

Job DetailsLevel:
Experienced Job Location: BDL Station - East Hartford, CT Position Type:
Full Time Education Level: 4 Year Degree Salary Range:
Undisclosed Travel Percentage:
Negligible Job Shift:
Day Job Category: QA - Quality Control Description

Position Purpose

To meet or exceed the expectations of our clients, each and every time we are of service to them. To respond quickly and proactively to challenges, in order to facilitate a quick and positive solution. To unselfishly perform any job-related task with a positive attitude and a high degree of accuracy. To help lead and mentor fellow team members in your department as well as other departments when they may need it.

To build strong working relationships with our present client base.

The Principal Quality Assurance Compliance Specialist/Coordinator (QAC) will be responsible for working with the Management Representative to develop, implement and maintain an ISO
13485 & 21

CFR Part
820 compliant Quality System.

Essential Tasks and Work Activities

• Act as the Owner and/or Coordinator for one or all of the following systems:
  Document Control, Product Release, Complaints, Management Review, CAPA, Supplier Program, Non-Conforming Products, Internal Audits, and/or other systems run by QA.
• Work closely with the Management Representative to develop, write, implement and train to Quality System processes and assures that the QMS maintains its effectiveness in accordance with applicable standards.
• Provide guidance as it relates to documented Quality System processes.
• Be responsible for coordinating the collection of Quality metrics from other departments for Management Review to include:
  Manufacturing, Resources, Regulatory, Corrective and Preventive Action status, internal audit results, receiving inspection, customer experience, supplier, and other metrics.
• Trend, monitor and support of the Complaints, Internal Audits, Supplier Program, NCP, and CAPA Systems to assure compliance with QSR, ISO 13485, and other quality system / customer requirements.
• Perform Internal Audits that are compliant with ISO
  13485 and FDA requirements.
• Have excellent organizational skills with ability to prioritize and work efficiently, effectively with minimum to no supervision on multiple tasks while being results oriented.
• Report on all of the above.
• Work adhering to global regulatory and Quality System requirements (US 21 CFR 820, ISO, etc.).
• This position assumes and performs other duties as assigned.

Work Activities

• Being responsible for compliance with applicable policies and procedures.
• Developing, implementing and maintaining monitoring systems by identifying critical process steps in processes and/or Quality Systems to capture quality metric data and execute / report trend analysis to lead process and compliance improvements.
• Providing input regarding compliance of Quality System processes to applicable Procedures, ISO/EN standards, FDA, QSR, Customer and applicable international requirements.
• Creating and providing training to company as it relates to Quality Systems or processes.
• A strong emphasis is placed on developing, implementing and maintaining the Complaints, CAPA, Supplier Program, Internal Audits, and/or other systems run by QA.

Qualifications

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions:

The Principal QAC must be able to work in a fast paced environment; must have the ability to work on multidisciplinary teams (internally and with customers); have strong verbal and written communication skills; demonstrate problem-solving, organizational, troubleshooting, time management, and decision making skills; be extremely detail oriented; have a sound understanding of global quality systems in the medical device environment and the creative application of such on-the-job.

Education and/or Experience

• Bachelor's degree from four-year College or university with 3 or more years related experience in Medical Device QA Compliance for US Class II or above Devices or 10 years of experience.
• Direct experience in Global Quality Systems (i.e., ISO
  13485, QSRs, etc.) and Medical Device Regulations (CFR, MDD, SOR, etc.) as it relates to department and job duties described within this document.
• The following is preferred but not required:
  • Class III product experience is a plus;
  • CQA preferred but not required.

About the company

PGL is the world’s fastest growing logistics company specializing in end-to-end design, implementation and operational capabilities in freight forwarding, contract logistics, as well as transportation and distribution management.

#J-18808-Ljbffr