Join the CQ Family.

 
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Benefits

  • Paid Cell Phone
  • Overtime
  • 401K Available after 1 year
  • Student Loan Repayment Program
  • Bi-Weekly Team Lunch
  • Paid Time Off

 

QA/RA Associate

This position is responsible to assist the Regulatory and Compliance management staff with implementation of best practices to optimize quality, efficiency and productivity in systems throughout CardioQuip and other CardioQuip facilities.

Specifically, the position is responsible for assisting with review of new and revised standards and regulations against current practices, supporting the effectiveness & compliance of CardioQuip's Quality System. As part of this responsibility, the position will also track and report progress of specific Quality System indicators for management review. Position will participate as an active compliance/independent representative on project teams. As part of the extended project team, this associate will be responsible for assuring that design history files are compliant with regulations and CardioQuip business needs, by verifying files at strategic milestones, including at the end of each design control phase. Position is also responsible for assisting with third party/regulatory audits. 

 

Job Details

  • Manages monitoring of new and revised standards and regulations 

  • Chairs External Standards Committee. 

  • Reports to CQ Management on changes impacting compliance to external standards and regulations. 

  • Reviews new and revised standards and regulations to verify compliance of CardioQuip systems 

  • May participate in Quality System or product enhancement projects 

  • Develops and maintains expertise in quality management standards, software and tools applicable to CardioQuip 

  • Implements through documentation practices, ISO 13485, CE Mark, GDP, validation and verification/qualification. 

  • Develops and maintains expertise in applicable quality regulations, including, but not limited to: U.S. Food and Drug Administration (FDA) current Good Manufacturing Practice (cGMP) for Medical Devices (21 CFR 820),  Health Canada cGMP, European MDD 93/42/3EC.

  • Provides ongoing reinforcement of compliance and quality culture. 

  • Acts as the lead instructor on all procedures and processes concerning quality management, regulatory requirements and design control management.

  • Designs training curriculum

  • Designs a system for monitoring and evaluating the effectiveness of training.

  • Establishes a training schedule

  • Reviews and drafts proposals to implement changes to the Quality System procedures/forms as needed to maintain compliance, improve effectiveness and efficiency (including all change order management)

  • Acts as independent reviewer on design control projects to ensure compliance with internal procedures and external standards and regulations. 

  • Assists and/or conducts internal audits to assess compliance with applicable regulations and standards (e.g. - Quality System Regulation (QSR), ISO 13485, ISO 14971, ISO 11607, ISO 11135/ EN550, ISO 11137/ EN552 and the amended Medical Device Directive).

  • Assists with third party/regulatory audits (Customer, Notified Body, FDA)

  • Monitors and remains current with internal company procedures/policies, international QS standards and regulations 

  • Assists the Compliance Director with tasks such as FDA correspondence and maintaining communication with all domestic and overseas CardioQuip facilities. These duties must be performed in such a manner as to assure that strict confidentiality is maintained. 

  • Performs other job related duties as assigned.

Job Qualifications

Knowledge, Skills and Abilities

  • Knowledge of national and international regulations applicable to medical devices including; Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EE. 
  • Preferred completion of an accredited Quality Management Systems Lead Auditor Training Course or equivalent (e.g. ASQ, ANSI-RAB NAP).
  • Proficiency in Apple OS applications, Microsoft Office applications, and Document Control software applications.
  • Ability to interact effectively with associates across all departments within an organization at all levels. 

Background and Experience      

  • Four-year degree preferred will consider Associates degree and significant work experience in QA/RA  within a regulated industry.
  • 3-5 Years’ experience in QA/RA in a regulated industry (medical device preferred)

  

Interested? Send your resume to

jobs@cardioquip.com

Our Hiring Process

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1. Apply

Now that you’ve found open positions, it’s time to start applying. Submit your resume to jobs@cardioquip.com.

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2. Interview

If you meet all of the qualifications, a recruiter may initiate the next steps – this can be a phone interview, pre-employment assessment or video interview.

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3. Offer & Welcome

After the Interview process, a hiring decision will be made. If you are offered a position, it will come as a verbal offer of employment, followed by an email when you accept.

4. Onboarding 

Congratulations on joining the CardioQuip family! Your hiring manager will convey further details including start dates, benefits and on-boarding information.