777 West Street Mansfield, MA 02048 US
This position is self-directed and is responsible for performing quality assurance tasks and activities with minimal guidance and supervision, detail oriented and strong computer skills to support the function of Remediation of Design History Files (DHF), Clinical Evidence Reports (CER) and Technical Files (EU-MDD/MDR Focused). Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements. Demonstrates an understanding of the relevant regulations, standards and operating procedures. Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements. This role is an Independent Contributor, and interaction is potentially with all levels of the organization. This position reports to R&D Manager. Receives general guidance may receive more detailed instruction on new projects.
Responsibilities for Quality Specialist:
- Lead document control functions, assuring revision control, reviews, updates and data integrity of all documents managed in the Oracle Agile PLM System.
- Converting and routing of documents in the Oracle Agile System.
- Works with global team members for approvals and product structures.
- Demonstrates knowledge of quality systems.
- Works well cross-functionally and has the ability to interpret standard operating procedures and regulatory requirements as well as educate others on those requirements.
- Works on projects of limited scope and complexity.
- Prepare and file all Device History Records and other documents, maintaining organization and retrievability.
- Perform, document, and review incoming and final inspections as required.
- Follows established procedures to resolve readily identifiable technical problems.
- Supports multiple aspects of compliance for the Quality System as needed.
- 2 years of experience
Required/Preferable Knowledge, Skills and Abilities for Quality Specialist:
- Use of Oracle Agile Software
- Demonstrates knowledge of quality systems
- Proficiency in Microsoft Office Software (Microsoft Word, Excel, et. al.)
- Excellent organizational skills
- Ability to assertively interact and communicate with people at all levels of the organization
- Good technical writing skills, grammar
- Ability to manage time and prioritize, as well as multi-task
- Ability to handle highly confidential business information
- Strong attention to detail
- Ability to think proactively
- Equivalent work experience, preferred experience in related field, preferred strong Microsoft Office Products usage
Although this hasn't been an issue at The Planet Group, 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 The Planet Group.