Staff Product Quality Engineer - Devens, MA
3 days ago
Job description
Job Purpose
The Staff Product Quality Engineer plays a hands-on role in driving product quality and regulatory compliance throughout the development and production of advanced metal additive manufactured components. This role is critical in building scalable, quality-focused processes that enable efficient production of high-performance parts, from prototyping through full-scale production. Working cross-functionally with R&D, Manufacturing, Operations, suppliers and customers, the Staff Product Quality Engineer will lead quality initiatives, process validations, and continuous improvement efforts, ensuring that products meet rigorous quality, reliability and regulatory standards.
Key Responsibilities
- Partner closely with R&D, Manufacturing and Operations to integrate quality controls from design through manufacturing, ensuring product designs are manufacturable at scale with minimal defects and meet customer and regulatory requirements.
- Serve as a core Quality team member during new product development and introduction activities, with focus on metrology and metallurgical testing.
- Provide hands-on support to manufacturing lines, driving root cause investigations and implementing effective corrective and preventive actions to resolve product and process quality issues.
- Promote awareness of Quality and Regulatory requirements across teams to ensure compliance with internal Quality Management System standards and external regulations (e.g., ASTM standards for Ti-6Al-4V).
- Set up and validate metrology inspection methods and mechanical/metallurgical testing protocols, including operator training.
- Develop and implement Statistical Process Control (SPC) and lead validation/verification of new and existing products and processes.
- Develop and maintain key quality system documentation including Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), change orders, and Master Validation Plans.
- Serve as a Material Review Board team member to evaluate and disposition of non-conformances.
- Investigate escalated product complaints to root cause and drive timely resolution.
- Monitor product and process performance metrics and act upon trends to drive continuous improvement to improve product quality and operational efficiency.
- Support supplier quality activities, including qualification audits, as a subject matter expert and ensure supplier materials meet quality criteria.
- Collaborate with suppliers and customers to address and resolve quality issues.
- Develop and implement quality control strategies for Ti-6Al-4V additive manufacturing processes; Establish and validate metallurgical test equipment for titanium alloys (e.g., Ti-6Al-4V), including tensile, hardness, density, and microstructure evaluations.
- Lead quality engineering projects, working across manufacturing engineering, operations quality control, metallurgical lab, and NPI teams, to develop and implement quality process controls to ensure compliance with AS9100, ISO 9001, and ISO 13485 standards.
Qualifications
- Bachelor's degree in Engineering, Mechanical Engineering, Materials Science, Quality, or related field preferred; equivalent hands-on experience will also be considered.
- 6+ years of quality engineering experience, ideally in advanced manufacturing or additive manufacturing environments.
- Strong knowledge of quality system standards and regulatory compliance, including GMP, FDA QSR, and ISO 13485.
- Proven experience with process validation, root cause analysis, data analysis, statistical process control (SPC), and corrective action implementation.
- Hands-on experience with titanium alloys (e.g., Ti-6Al-4V) additive manufacturing processes is a strong plus.
- Strong organizational, analytical, and problem-solving skills in a manufacturing environment.
- Proficiency in metrology techniques and mechanical/metallurgical testing methods.
- Demonstrated ability to lead cross-functional projects, influence stakeholders, and drive quality initiatives from concept through production.
- Excellent communication skills with experience interfacing with suppliers and customers.
- Lean, Six Sigma, or similar continuous improvement certification is a plus.
VulcanForms offers a competitive salary and equity package. Actual compensation is based on factors such as the candidate's skills, qualifications, and experience. In addition, VulcanForms provides comprehensive benefits including medical, dental, vision, and life insurance; generous paid time off; and a 401(k) plan with company match.
The annual base salary range for this position is $117,477-$161,531.
Similar jobs
A fast-growing manufacturing company seeks a Process Validation resource to support their expanding operations team. · Develop and execute process validation plans protocols reports for new existing manufacturing processes. · Lead facilitate Process Failure Modes Effects Analysis ...
1 month ago
A Quality Engineer at SMC Ltd. will ensure that every product meets the highest standards of quality and compliance by collaborating with cross-functional teams and supporting continuous improvement initiatives. · ...
1 month ago
A fast-growing manufacturing startup is seeking a Quality Engineer with a strong background in materials science and hands-on metrology to support its expanding operations. · Bachelor's degree in Materials Science, Mechanical Engineering, or related field. · 3+ years of experienc ...
1 month ago
Responsible for all areas of Quality Engineering and working directly with the engineering... · ...
1 month ago
Expanding small manufacturer of machined and electromechanical products is looking for Quality Engineer to drive quality initiatives that directly impact customer satisfaction and product excellence. · This influential role uses your technical expertise allowing you to shape the ...
2 weeks ago
Job Title: · Senior Quality Engineer · Location: · US Supply - Devens · Location Type: · On-Site · Website: · Group: · When you join Watson-Marlow Fluid Technology Solutions, a part of the Spirax Group, you will be integrated into a cooperative and encouraging team, participate i ...
2 days ago
We're looking for an experienced Manager to lead our Quality Engineering team at our Devens Cell Therapy Facility in Massachusetts. As Manager of Quality Engineering you will provide quality oversight of qualification and validation activities for the facility's startup operation ...
3 days ago
Job Title: Senior Quality Engineer · Location: US Supply - Devens · Location Type: On-Site · Website: · Group: · When you join Watson-Marlow Fluid Technology Solutions, a part of the Spirax Group, you will be integrated into a cooperative and encouraging team, participate in ch ...
2 days ago
Expanding small manufacturer of machined and electromechanical products is looking for a Quality Engineer/Technician to drive quality initiatives that directly impact customer satisfaction and product excellence. This influential role uses your technical expertise allowing you to ...
2 hours ago
As a Quality Engineer II at SMC Ltd., you'll play a key role in ensuring that every product we produce meets the highest standards of quality and compliance. · Create and maintain pFMEA's, Control Plans, PPAPs, Master Validation Plans, IQ/OQ/PQ protocols and reports. · Analyze FA ...
1 month ago
+Transforming patients' lives through science+ · +BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.+ · +The Manager, Quality Engineeri ...
1 week ago
We're looking for a Manager, Quality Engineering to provide quality oversight of qualification and validation activities at our Cell Therapy Facility in Devens, MA. · Review and approve commissioning and qualification lifecycle documentation associated with manufacturing site fac ...
4 days ago
The Manager, Quality Engineering at the Cell Therapy Facility (CTF) in Devens, MA will be responsible for providing Quality oversight of qualification and validation activities. · ...
1 month ago
Job Title: Senior Quality Engineer · Location: US Supply - Devens · Location Type: On-Site · Website: · Group: · When you join Watson-Marlow Fluid Technology Solutions, a part of the Spirax Group, you will be integrated into a cooperative and encouraging team, participate in ch ...
2 days ago
We're hiring a Senior Quality Engineer II to support and strengthen our Quality function in a fast-paced manufacturing environment. · Support the Quality Manager with returns, source inspections, and quality initiatives · Serve as the primary customer contact for quality issues a ...
2 weeks ago
The Manager Quality Engineering at Cell Therapy Facility will provide quality oversight qualification validation activities change control for startup continuing operations Devens MA facility including commissioning qualification validation CQV computer systems validation CSV pro ...
1 month ago
Job Purpose · The Staff Product Quality Engineer plays a hands-on role in driving product quality and regulatory compliance throughout the development and production of advanced metal additive manufactured components. This role is critical in building scalable, quality-focused pr ...
3 days ago
At Parker Aerospace we develop technologies and innovative solutions that enable reliable efficient and increasingly sustainable flight for the lifecycle of the aircraft including aftermarket support Our passionate people with deep engineering expertise together with our breadth ...
3 weeks ago
The Staff Product Quality Engineer plays a hands-on role in driving product quality and regulatory compliance throughout the development and production of advanced metal additive manufactured components. · Bachelor's degree in Engineering, Mechanical Engineering, Materials Scienc ...
1 month ago
The Staff Product Quality Engineer plays a hands-on role in driving product quality and regulatory compliance throughout the development and production of advanced metal additive manufactured components. · Partner closely with R&D, Manufacturing and Operations to integrate qualit ...
2 weeks ago