Specialist, Quality Compliance

Edwards Lifesciences; California (MO); On-site; USD 66,000 - 94,000; Full time

Job summary

A leading company in the medical equipment sector is looking for a Quality Specialist to enhance patient outcomes through compliance and quality assurance in device handling. The role requires evaluations against regulatory standards while managing customer relations and improving internal processes through detailed assessments and teamwork. You will lead investigations and ensure compliance with medical device regulations, contributing significantly to product lifecycle management.

Qualifications

• 3 years’ experience in complaint handling is required.
• Experience in medical devices or healthcare settings is beneficial.

Responsibilities

• Assess and evaluate complaint information.
• Manage customer relationships during investigations.
• Prepare and submit Medical Device Reporting (MDR) reports to FDA.

Skills

Problem-solving

Communication

Attention to detail

Education

Bachelor's Degree in related field

Tools

MS Office Suite

Job description

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. In this role you will fulfill FDA, ISO and other relevant requirements for designated complaint handling unit, and evaluation of events for reportability to applicable regulatory bodies.

How you will make an impact:

• Assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate
• Manage customer relationships and expectations during the course of complaint investigation and resolution process
• Research, seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations
• Identify problems and lead projects to improve processes, procedures, and/or practices; recommend solutions, including devising new approaches to problems encountered
• Evaluate complaints for Medical Device Reporting (MDR); prepare and submit MDR reports to FDA
• Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions
• Prepare and submit final customer correspondence
• Assist in planning agendas and running weekly meetings to discuss complaint issues with affected functions (e.g., Manufacturing, Quality Assurance, Suppliers, etc.) to identify assignable root cause, resolve open action items, and gather additional technical information to resolve complaint
• Other duties assigned by Leadership (May assist in auditing complaint files)
  
  

What you'll need (Required):

• Bachelor's Degree in related field , 3 years’ experience complaint handling
• Medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment
  
  

What else we look for (Preferred):

• Proven expertise in MS Office Suite and ability to operate general office machinery
• Excellent written and verbal communication skills and interpersonal relationship skills
• Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment required
• Demonstrated problem-solving , critical thinking, and investigative skills Ability to build stable working internal/external relationships
• Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance
• Good knowledge of medical terms and human anatomy
• Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations
• Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
• Ability to manage confidential information with discretion
• Attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and representing the department on specific projects
• Ability to build productive internal/external working relationships
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
  
  

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $66,000 to $94,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

Referrals increase your chances of interviewing at Edwards Lifesciences by 2x

Get notified about new Quality Specialist jobs in California, United States.

Sunnyvale, CA $111,100.00-$152,800.00 1 week ago

Supplier Quality Engineer - Electromechanical (Hybrid Mechanical and Electrical)

Menlo Park, CA $98,000.00-$112,000.00 5 hours ago

Santa Clarita, CA $75,000.00-$90,000.00 1 day ago

California, United States $35.00-$45.00 2 days ago

Senior Quality Engineer - Medical Device Client

Santa Rosa, CA $82,000.00-$130,000.00 6 days ago

Gardena, CA $80,000.00-$95,000.00 6 days ago

Irvine, CA $89,000.00-$118,560.00 5 days ago

Los Angeles, CA $100,000.00-$130,000.00 22 hours ago

Senior Quality Engineer (Aerospace & Defense)

Long Beach, CA $100,000.00-$150,000.00 6 days ago

San Diego Metropolitan Area $55.00-$65.00 5 days ago

Sunnyvale, CA $102,000.00-$164,000.00 2 weeks ago

Santa Clara, CA $168,000.00-$264,500.00 6 days ago

Long Beach, CA $69,000.00-$87,000.00 6 days ago

Carson, CA $75,560.00-$100,000.00 6 days ago

Irvine, CA $69,000.00-$87,000.00 6 days ago

San Luis Obispo, CA $130,000.00-$150,000.00 6 days ago

Oxnard, CA $110,000.00-$130,000.00 6 days ago

Carlsbad, CA $80,000.00-$90,000.00 2 days ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.