Senior Manufacturing Quality Engineer

3 weeks ago

Woburn, United States CareerBuilder Full time

Covaris, LLC

(www.covaris.com) is a profitable technology company headquartered in Woburn, Massachusetts, USA. Covaris has developed a proprietary and patented Adaptive Focused Acoustics (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 Senior Manufacturing 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.
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.
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
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:
Bachelors 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 Whys, 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.

Category: Exempt

#J-18808-Ljbffr

  • Senior Quality Engineer

    2 weeks ago

    Woburn, Massachusetts, United States SES AI Corp Full time

    Senior Quality Engineer About UsSES is a global leader in development and production of high-performance Li-Metal rechargeable batteries for electric vehicles (EVs) and other applications. Founded in 2012, SES is an integrated Li-Metal battery manufacturer with strong capabilities in material, cell, module, AI-powered safety algorithms and recycling....

  • Quality Engineer

    3 weeks ago

    Woburn, United States Servomex Full time

    Servomex, the world leader in gas analysis, is looking to expand our Quality Team. This is an exciting opportunity for a Quality Engineer to join our high performing team at our site in Woburn, MA. The successful candidate will work closely with our manufacturing teams at our US Technical Center (Woburn) to build quality through all of what we do. Reporting...

  • Quality Engineer

    3 weeks ago

    Woburn, United States Servomex Full time

    Servomex, the world leader in gas analysis, is looking to expand our Quality Team. This is an exciting opportunity for a Quality Engineer to join our high performing team at our site in Woburn, MA.The successful candidate will work closely with our manufacturing teams at our US Technical Center (Woburn) to build quality through all of what we do. Reporting...

  • Quality Engineer

    3 weeks ago

    Woburn, United States Servomex Full time

    Servomex, the world leader in gas analysis, is looking to expand our Quality Team. This is an exciting opportunity for a Quality Engineer to join our high performing team at our site in Woburn, MA.The successful candidate will work closely with our manufacturing teams at our US Technical Center (Woburn) to build quality through all of what we do. Reporting...

  • Quality Engineer

    3 weeks ago

    Woburn, United States Servomex Full time

    Servomex, the world leader in gas analysis, is looking to expand our Quality Team. This is an exciting opportunity for a Quality Engineer to join our high performing team at our site in Woburn, MA.The successful candidate will work closely with our manufacturing teams at our US Technical Center (Woburn) to build quality through all of what we do. Reporting...

  • Quality Engineer

    5 days ago

    Woburn, United States Servomex Full time

    Servomex, the world leader in gas analysis, is looking to expand our Quality Team. This is an exciting opportunity for a Quality Engineer to join our high performing team at our site in Woburn, MA.The successful candidate will work closely with our manufacturing teams at our US Technical Center (Woburn) to build quality through all of what we do. Reporting...

  • Quality Engineer

    7 hours ago

    Woburn, United States Servomex Full time

    Servomex, the world leader in gas analysis, is looking to expand our Quality Team. This is an exciting opportunity for a Quality Engineer to join our high performing team at our site in Woburn, MA.The successful candidate will work closely with our manufacturing teams at our US Technical Center (Woburn) to build quality through all of what we do. Reporting...

  • Quality Engineer

    5 days ago

    Woburn, United States Servomex Full time

    Servomex, the world leader in gas analysis, is looking to expand our Quality Team. This is an exciting opportunity for a Quality Engineer to join our high performing team at our site in Woburn, MA.The successful candidate will work closely with our manufacturing teams at our US Technical Center (Woburn) to build quality through all of what we do. Reporting...

  • Manufacturing Quality Assurance

    1 week ago

    Woburn, United States TalentBurst Full time

    Title: Manufacturing Quality Assurance Location: Woburn, MA Duration: 12+ Months Client is a profitable technology company headquartered in Woburn, Massachusetts, USA. Client has developed a proprietary and patented Adaptive Focused AcousticsTM (AFA) technology platform which is utilized in sample preparation processes in the analytical and life sciences...

  • Quality Engineer

    3 weeks ago

    Woburn, United States SolidEnergy Systems Full time

    Quality Engineer About Us SES is a global leader in development and production of high-performance Li-Metal rechargeable batteries for electric vehicles (EVs) and other applications. Founded in 2012, SES is an integrated Li-Metal battery manufacturer with strong capabilities in material, cell, module, AI-powered safety algorithms and recycling. Formerly...

  • Quality Engineer

    1 week ago

    Woburn, United States EHR SERVICES LLC Full time

    Covaris, LLC. (www.covaris.com) is a profitable technology company headquartered in Woburn, Massachusetts, USA. Covaris has developed a proprietary and patented Adaptive Focused Acoustics (AFA) technology platform, which is utilized in sample preparation processes in the analytical and life sciences industries worldwide. Covaris AFA has become the gold...

  • Quality Engineer

    2 weeks ago

    Woburn, United States EHR Services Full time

    Job DescriptionJob DescriptionCovaris, LLC. (www.covaris.com) is a profitable technology company headquartered in Woburn, Massachusetts, USA. Covaris has developed a proprietary and patented Adaptive Focused Acoustics™ (AFA) technology platform, which is utilized in sample preparation processes in the analytical and life sciences industries worldwide....

  • Senior Mfg Engineer

    1 week ago

    Woburn, United States Boyd Company Full time

    Job Description Senior Manufacturing Engineer - Systems Boyd Corporation is a market leader and manufacturer of high-performance cooling products for use in the aerospace, military, alternative energy, enterprise and medical markets. Our continued growth has created an immediate opening for a Sr. Manufacturing Engineer within the Operations Team. We are...

  • Sr Manufacturing Engineer

    1 week ago

    Woburn, United States Katalyst HealthCares & Life Sciences Full time

    Responsibilities: Develop and execute required validations in line with regulatory requirements to include Equipment, Process & Product validations. Develop Specification, Procurement, Installation, and Validation of Manufacturing Equipment, including on site Factory Acceptance Testing of equipment. Provide ongoing day to day support to Production;...

  • Sr Manufacturing Engineer

    1 week ago

    Woburn, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities: Develop and execute required validations in line with regulatory requirements to include Equipment, Process & Product validations. Develop Specification, Procurement, Installation, and Validation of Manufacturing Equipment, including on site Factory Acceptance Testing of equipment. Provide ongoing day to day support to Production;...

  • Quality Engineer

    3 weeks ago

    Woburn, United States Motion Recruitment Full time

    Our client is a leading innovator in the medical device industry, dedicated to improving healthcare outcomes through cutting-edge technologies. They are seeking a highly skilled and motivated Quality Engineer specializing in Design Assurance to join their dynamic team. As a Quality Engineer, you will play a critical role in ensuring the quality and...

  • Senior Software Engineer

    2 days ago

    Woburn, United States Cytrellis Biosystems Inc Full time

    HIRING! Senior Software Engineer! We're looking for passionate and ambitious individuals to join the Cytrellis Team! What makes Cytrellis different: • Unique product offering - ellacor by Cytrellis is the FIRST and ONLY FDA-cleared device for non-surgical, scarless skin removal. • Untapped Market Potential: 5x account growth in the last 8 months •...

  • Senior Software Engineer

    1 week ago

    Woburn, United States Cytrellis Biosystems Inc Full time

    HIRING! Senior Software Engineer! We're looking for passionate and ambitious individuals to join the Cytrellis Team! What makes Cytrellis different: • Unique product offering - ellacor by Cytrellis is the FIRST and ONLY FDA-cleared device for non-surgical, scarless skin removal. • Untapped Market Potential: 5x account growth in the last 8 months •...

  • Senior Mechanical Engineer

    1 week ago

    Woburn, United States Boyd Company Full time

    Job DescriptionJob Description – Senior Mechanical Engineer June 20, 2023 Job Summary: Hands-on Mechanical Engineer responsible for designing mechanical systems used in liquid cooling system products. This person would work with a small team of refrigeration, electrical and manufacturing engineers to bring the new product though its full product...

  • Senior Software Engineer

    2 weeks ago

    Woburn, United States Cytrellis Biosystems Full time

    Job DescriptionJob DescriptionSalary: ➡️ HIRING! Senior Software Engineer!We’re looking for passionate and ambitious individuals to join the Cytrellis Team! What makes Cytrellis different:✔️ Unique product offering – ellacor by Cytrellis is the FIRST and ONLY FDA-cleared device for non-surgical, scarless skin removal. ✔️ Untapped Market...