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Remote Sr Quality Systems Spec

Larkfield, CA 95403

Posted: 08/30/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 613580 Is job remote?: Yes Country: United States

Job Description


Pay 45-55 depending on experience

HM's Top Needs:

1. Design Control

2. Experience in ISO 13485      

3. Class III medical device experience
 

Education Required:  Bachelors degree

Years’ Experience Required:  Bachelors degree with 4+ years of work experience or 2 years with advanced degree.



Senior Quality Systems Specialist 

Careers That Change Lives

 

In this exciting role as a Sr. Quality Systems Specialist you will have responsibility for compliance to Quality System processes and Medical Device regulations and requirements. 

Structural Heart and Aortic

The Structural Heart and Aortic integrated operating unit offers minimally-invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves—aortic, pulmonic, mitral, tricuspid—and the placement of stent grafts to treat aneurysms and dissections of the body’s largest artery, the aorta

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

 
  • Provide continuous and rigorous assessment of quality system to assure compliance with internal policies in general and specific to quality system processes, FDA part 820.30 regulations (Design Controls, specifically Design Changes), ISO 13485, Medical Device Requirements, and governmental regulations.

 
  • Participates in Quality System process activity across multiple sites including quality system projects and initiatives.

 
  • Participate in, and own CAPA management activities, including corrective actions and effectivity strategies.

 
  • Conduct root cause investigations of Quality System compliance issues; complete data analysis on investigation findings.

 
  • Support the development and implementation of Quality System procedures.

 
  • Performs other related duties as assigned.

 

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

 

Bachelor's degree with 4+ years of work experience in Quality, Manufacturing, or regulated industry OR Advanced degree with 2 years of work experience in Quality or regulated industry

 

Desired Skills

 
  • Experience in a regulated environment

 
  • Experience working with audit findings, corrections, and corrective actions

 
  • Experience in medical device, pharmaceutical and/or a comparable regulated environment

 
  • Influence management skills; ability to work constructively across all functions of the organization as well as external customers

 
  • Project management skills

 
  • Quality System documentation systems (e.g. Agile) and Audit documentation systems experience (e.g. Trackwise)

 
  • Experience reviewing technical documentation

 
  • Strong written and verbal communication skills

 
  • Ability to educate people in Quality Systems and the Audit program

 
  • Experience with quality tools and process improvement techniques

 
  • Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques

 
  • Strong analytical and decision-making skills

 
  • Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and company quality requirements in general and specific to CAPA.


Together, we can change healthcare worldwide. At this company, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

 

Travel 10% domestic and internationally

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Larkfield, CA

Unlock new career possibilities in the vibrant community of Larkfield, California! Nestled in Sonoma County, Larkfield offers a perfect blend of picturesque landscapes, renowned wineries, and a thriving arts scene. From the lush vineyards of Wine Country to the charming boutiques in downtown Santa Rosa, this region provides endless opportunities for personal and professional growth. Don't miss out on the chance to explore job opportunities near landmarks like the Luther Burbank Center for the Arts, Annadel State Park, and the Santa Rosa Plaza. Join us in Larkfield, where career success meets the enchanting beauty of Northern California!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.