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Quality Engineer I

Santa Ana, CA 92705

Posted: 09/10/2024 Employment Type: Contract Job Category: Engineering Job Number: 614078 Is job remote?: No Country: United States

Job Description


HM's Top Needs:
1. Experience in Complaint handling, complaint investigation and root cause analysis for Medical Devices
2. Ability to work cross-functionally, and deliver consistent outputs to meet set targets.
3. Strong knowledge of Cardiovascular diseases, use of heart valves and catheters
 

Education Required: Bachelor’s degree in Science/Engineering

Years’ Experience Required: minimum 2 years

Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours

Work Location:

                Do they need to be local to any MDT office and if so where? Yes, local to Santa Ana, CA or Orange County area

Does this person need to be on site? If so, full time or part time? Flex i.e. part time on site.


Responsibilities may include the following and other duties may be assigned.
  • Conducts complaint investigations for Structural Heart devices. This includes performing intial assessment to create appropriate tasks or technical assessments in the Global Complaint Handling (GCH) system, for example - DHR reviews, Manufacturing assessment, R&D assessment,etc. Performing thorough review of these assessments by working with the cross-functional teams (like Medical Safety, Manufacturing, Operations Quality, R&D, Design Assurance and Customer Quality Teams) across multiple sites and time zones globally. Summarizing the results of these assessment into the  complaint investigation summary in a timely manner to ensure timely closure of the overall event.
  • To be able to consistently close complaint investigations to meet weekly target volumes. Ensuring timely completion of complaint investigations to sustain a compliant timeliness metric/KPI for the entire Operating unit.
  • Presenting complaints on a weekly basis and escalating events that meet certain criteria. To be able to communicate complaint information across all levels in the organization.
  • Supporting regulatory submissions and regulatory inquries on complaints by working closely with Customer Quality Experience Management team (CQXM) and providing complaint data as requested.
  • Ability to present the complaint investigation in an audit when needed. 
TECHNICAL SKILLS
Must Have
  • Anatomy and physiology
  • Complaint Handling
  • Customer Complaint Investigations
  • Highly proficient in Microsoft Excel, Word, PowerPoint
  • · Medical device experience
  • Root Cause Analysis
  • Strong Communication Skills
  • Technical Writing

Nice To Have
  • Complaint Trending
  • Data Analysis
  • Experience in Heart Valve Therapy
  • Experience with Cardiovascular devices
  • Heart disease states
  • Risk Management

DIFFERENTIATING FACTORS
Autonomy: Entry-level individual contributor on the post market quality team. Works with close supervision.
Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.
Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.
Makes minor changes in systems and processes to solve problems.
Communication and Influence: Communicates primarily with internal contacts across all levels within the operating unit.
Contacts others to gather, confirm and convey information.
Leadership and Talent Management: N / A – job at this level is focused on self-development.
Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A), 0 years of experience required.

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 Santa Ana, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant city of Santa Ana, California, where endless possibilities await. Nestled in Orange County, Santa Ana offers a delightful blend of diverse cultures, stunning art galleries like the Bowers Museum, theaters such as the Yost Theater, and mouthwatering cuisine at the 4th Street Market. Home to the professional sports teams like the Orange County Soccer Club, this city also boasts serene parks like Santiago Park for outdoor enthusiasts. Come be a part of a community brimming with charm and growth opportunities – your dream job could be just a click away.

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.