Role: Quality Compliance Analyst

Team

Reports to: Manager of Quality Systems

Job Description:

The Quality Compliance Analyst will be the primary contact for all post market surveillance activities, the lead of the CAPA program, and the corrections & removals program. They will be responsible for monitoring and managing complaint processing and adverse event determination, CAPA management, corrections & removals process development, and metrics reporting. This includes working cross-functionally to investigate product malfunctions, product design and/or labeling questions, as well as customer dissatisfaction issues, and the regular monitoring and reporting of complaint handling status. They will monitor metrics and drive process improvements based on performance trends. This individual will contribute to complaint handling, and correction & removals process requirements, including updating SOPs and Work Instructions to ensure compliance with domestic regulations such as 21 CFR Part 802.198 & 803 & 806 and build process to be compliant with evolving global regulations and standards such as the EU-MDD/MDR and ISO13485: 2016. The incumbent for this position will support additional activities as assigned. 

 

Key Performance Elements/Essential Functions:

  • Responsible for processing complaints & facilitating investigation throughout the complaint lifecycle to ensure proper documentation and timely closure
  • Leads Complaint Assessment Board to perform review potentially reportable complaints per Medical Device Regulations
  • Responsible for working with Regulatory Affairs to ensure on time reporting of MDRs
  • Leads CAPA Review Board to facilitate closure of open CAPAs, and review CAPA extensions and escalations
  • Establishes Quality Data Metrics related to Complaints, CAPAs and other QMS processes
  • Serve as a backroom subject matter expert (SME) for complaint processing, complaint investigation, MDR determinations, and CAPAs during audits
  • Collaborates internally to develop & manage the corrections and removals process including appropriate feeders and tie in with other processes (design controls, complaints, CAPA, production, etc.)
  • Organize and analyze data highlighting trends in preparation for Management Review meeting
  • Offers new ideas and continually drives quality system improvement Performs all other duties as assigned

 Requirements/Qualifications

  • B.S. in Engineering, Sciences, S.T.E.M. or similar/equivalent preferred
  • Minimum of 10 years of experience in medical device industry required
  • Advanced knowledge of Medical Device Complaint files and quality record documentation
  • Advanced knowledge of Quality Management System and Regulatory reporting requirements for Medical Devices (21 CFR Part 820.198 and 803 requirements, EU MDD/MDR requirements)
  • Previous complaint handling experience with radiation therapy equipment preferred
  • Previous experience with corrections & removals (21 CFR 806) preferred
  • Ability to work effectively in a collaborative and dynamic environment
  • Leadership and interpersonal skills to develop and manage good working relationships with internal departments (quality, operations, engineering, medical affairs, clinical, and regulatory); strong written and verbal communication skills

 

Apply for this Job

* Required

  
  
When autocomplete results are available use up and down arrows to review
+ Add Another Education


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at RefleXion Medical are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Form CC-305

OMB Control Number 1250-0005

Expires 1/31/2020

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

Because we do business with the government, we must reach out to, hire, and provide equal opportunity to qualified people with disabilities1. To help us measure how well we are doing, we are asking you to tell us if you have a disability or if you ever had a disability. Completing this form is voluntary, but we hope that you will choose to fill it out. If you are applying for a job, any answer you give will be kept private and will not be used against you in any way.

If you already work for us, your answer will not be used against you in any way. Because a person may become disabled at any time, we are required to ask all of our employees to update their information every five years. You may voluntarily self-identify as having a disability on this form without fear of any punishment because you did not identify as having a disability earlier.

How do I know if I have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Blindness
  • Deafness
  • Cancer
  • Diabetes
  • Epilepsy
  • Autism
  • Cerebral palsy
  • HIV/AIDS
  • Schizophrenia
  • Muscular dystrophy
  • Bipolar disorder
  • Major depression
  • Multiple sclerosis (MS)
  • Missing limbs or partially missing limbs
  • Post-traumatic stress disorder (PTSD)
  • Obsessive compulsive disorder
  • Impairments requiring the use of a wheelchair
  • Intellectual disability (previously called mental retardation)
Reasonable Accommodation Notice

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.