Quality Engineer - EHR Services

Covaris, LLC. (www.covaris.com) is a profitable technology company headquartered in Woburn, Massachusetts, USA. Covaris has developed a proprietary and patented Adaptive Focused Acousticsâ„¢ (AFA) technology platform, which is utilized in sample preparation processes in the analytical and life sciences industries worldwide. Covaris AFA has become the gold standard for DNA fragmenting in the Next Generation Sequencing market. Covaris AFA is used by the largest and most productive genome centers worldwide.

Covaris AFA and other proprietary products have unique and competitive advantages for scientists in genomics, proteomics, and epigenomics research.

Job Summary:

The Quality Engineer will play a key role in implementing an efficient ISO-13485 / IVDR-compliant environment: The Quality Engineer will report directly to the Director of QA/RA. A high level of independent activity is expected. The majority of the time, the position is on-site.

• Manufacturing support:
• Support manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containments.
• Ensure manufacturing activities follow QMS.
• Support development and execution of process validation and verification test plans, protocols, and reports.
• Support production and work cross-functionally on the issues and drive continuous improvement projects.
• Support investigation and disposition of non-conformances, both internal and supplier-related.
• Support implementation and improvement of manufacturing-related quality processes.
• Continuous Improvement:
• Lead and manage quality initiatives in multiple product and process quality areas. Ensure successful, on-time completion of continuous improvement projects.
• Support internal and external audits, prepare and review back-room documentation.
• Own change order and deviation processes.
• Escalate potential issues that could impact compliance, reliability, cost, and quality.
• Maintain technical documentation in support of IVDR Class A systems.
• Perform other duties as assigned

Essential Responsibilities: The employee may be required to perform all or a combination of the following essential responsibilities as determined by business necessity.

• Conduct investigations of identified problems with existing products in the field and production. Use Complaints, NCMR, CAPA, and DCO processes to modify product design or manufacturing procedures as required.
• Administer and improve quality processes, with a focus on Lean process management.
• Assist manufacturing and product development with documentation, guidance, and execution of design verification/validation and process validation.

Non-Essential Responsibilities: The employee may be required to perform other non-essential functions, follow any other job-related instructions, and perform any other job-related duties requested by their supervisor.

Qualifications:

• Bachelor's degree (minimum) in an engineering, technical or scientific discipline or equivalent.
• Pragmatic, entrepreneurial personality and strong self-starter. Continually strives to improve.
• A minimum of 5+ years of working experience in Quality Engineering or regulated manufacturing (e.g., IVD, Medical Device, Automotive, etc.) is required.
• Proficient with the generation and execution of qualifications, validation protocols, and quality assurance procedures.
• Understand design controls, change controls, product, and engineering processes.
• Demonstrated track record with 21 CFR 820, ISO 13485, or equivalent quality regulations.
• Proficient in statistical process controls & Six Sigma methodology and tools (e.g. uses DMAIC process and basic tools such as 5 Why's, control charts, fishbone diagram).
• Proficient in typical Excel data analysis operations (e.g. Vlookup, Pivot table, and pivot chart functions). Able to create multi-source reports, trends, and interpret data with minimal oversight.
• Communicates effectively both verbally and in writing
• Acts decisively with Integrity and Kindness.

Reasonable Accommodation:Covaris is committed to the spirit and the letter of the Americans with Disabilities Act. All requirements are subject to possible modification to reasonably accommodate otherwise qualified individuals.