- Supplier Management
- Maintain supplier database and assess potential new suppliers for technical, quality and manufacturing capabilities. Provides technical support for the introduction of components from a new supplier.
- Conduct supplier quality audits (ISO 9001/13485) on a regular basis to ensure vendors and their suppliers remain in compliance.
- Generate qualification test protocols/FAI, monitor testing, complete test reports and approve components for use in production.
- Initiate Supplier Corrective Actions and ensure complete and effective Root Cause Analysis and Corrective Action implementation.
- Manufacturing / Sustaining
- Provide quality and compliance input for project decisions and deliverables including Design Changes, Test Methods, Design V&V, Usability Testing, Process Changes, Process Validation, and Labeling.
- Support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed internal quality as well as regulatory requirements.
- Provide key quality trending information and data for Management Review and Complaint Reviews.
- Support/conduct product investigations including complaints, CAPA, Nonconforming material, etc.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (e.g., 5 why's analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies).
- Bachelor's degree in Mechanical, Biomedical, Electrical or other engineering discipline
- 3+ years of medical device experience required.
- Advanced degree is a plus.
- CQE certification is a plus.
- Detailed understanding of US and International regulations including 21 CFR 820, Medical Device Directive, EUMDR, EN ISO 13485, and EN ISO 14971.
- Experience in manufacturing floor and working with contract supplier manufacturing process.
- Experience with Supplier audits and Supplier Corrective Actions.
- Experience in process validation, design controls, risk management, and CAPA.
- Familiar with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
- Ability to manage several projects.
- Effective research and analytical skills
- Effective written and oral communication, technical writing and editing skills.
- Domestic travel up to 20%
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Quality/Supplier Engineer - Waltham, United States - Convergent Dental Inc
Description
Job Description
Job DescriptionConvergent Dental has developed and launched Solea, a dental laser that can cut tissue in the oral cavity without anesthesia. Solea has quickly become the #1 hard and soft tissue laser in dentistry. This is an exciting time to join our amazing team. With our innovative technology we are looking to change the world of dentistry for dentists and their patients.
In this position you matter. This role fills a critical need and contributes significantly toward our company's success.
Job Summary:
The Quality/Supplier Engineer will primarily support the supplier management, manufacturing, and sustainment of the Solea product. This position will interact externally with contract manufacturers and other component suppliers, and internally with key functions including Manufacturing, Research & Development, Regulatory, Marketing, Customer Success, IT, and Field Service. We are looking for a hands-on, highly motivated, driven individual that can also work independently. The candidate will thrive in a fast-paced environment that rewards bright, self-starting, energetic, focused individuals seeking increasing responsibility and challenge. This position will report to the Director of Quality & Regulatory Affairs.
Primary Responsibilities:
Our Corporate Office is located in Waltham, MA This position will be hybrid (3-5 days in the office).
Convergent Dental is committed to developing a diverse and talented team. All candidates are encouraged to apply. If you are excited about this role but are unsure whether you meet 100% of the requirements, we encourage you to inquire and/or apply.
Disclaimer for Recruitment Agencies
Convergent Dental, Inc. does not accept unsolicited resumes from recruiters or employment agencies nor are we looking to add any search firms in response to our Careers page or any job posting or social media post. Convergent Dental, Inc. will not consider or agree to payment of any referral compensation or recruiter fee relating to these unsolicited resumes. Convergent Dental, Inc. explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes received, including those submitted to hiring managers, are deemed to be the property of Convergent Dental, Inc.
