Principal Quality Engineer
Devens, MA
As Principal Quality Engineer, you'll be a hands-on leader shaping product quality and regulatory compliance across the full lifecycle of our advanced metal additive manufactured components — from early development through high-volume production. You'll help design and scale the quality processes that make it possible to produce high-performance parts efficiently and reliably. Partnering across R&D, Manufacturing, Operations, suppliers, and customers, you'll drive quality initiatives, lead process validations, and champion continuous improvement so our products consistently meet the highest standards for quality, reliability, and compliance.
Responsibilities
- Embed quality into every stage of the product lifecycle by working closely with R&D, Manufacturing, and Operations to ensure designs are scalable, manufacturable, and aligned with customer and regulatory requirements.
- Act as a core quality representative during new product development and introduction (NPD/NPI), with particular focus on metrology and metallurgical testing.
- Support manufacturing teams on the floor — leading root cause investigations and implementing corrective and preventive actions (CAPA) to resolve product and process issues.
- Build organization-wide awareness of quality and regulatory expectations, ensuring alignment with our Quality Management System and external standards (e.g., ASTM specifications for Ti-6Al-4V).
- Establish and validate metrology inspection methods and mechanical/metallurgical testing protocols, including training operators on proper execution.
- Design and deploy Statistical Process Control (SPC) frameworks; lead verification and validation activities for both new and existing products and processes.
- Own and maintain critical quality documentation, including Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), change orders, and Master Validation Plans.
- Participate on the Material Review Board (MRB) to evaluate and disposition non-conformances.
- Lead investigations into escalated customer complaints, driving each to root cause and timely resolution.
- Track product and process performance metrics, identifying trends and turning them into continuous improvement opportunities.
- Serve as a subject matter expert for supplier quality activities — including qualification audits — and ensure incoming materials meet defined quality criteria.
- Collaborate directly with suppliers and customers to resolve quality issues.
- Develop and implement quality control strategies tailored to Ti-6Al-4V additive manufacturing; qualify and validate metallurgical test equipment for tensile, hardness, density, and microstructure evaluations.
- Lead cross-functional quality engineering projects spanning manufacturing engineering, operations QC, the metallurgical lab, and NPI — implementing controls that satisfy AS9100, ISO 9001, and ISO 13485.
Qualifications
- Bachelor’s degree in engineering, Mechanical Engineering, Materials Science, Quality, or a related field preferred; equivalent hands-on experience will also be considered.
- 6+ years of quality engineering experience, ideally in advanced or additive manufacturing.
- Deep familiarity with quality system standards and regulatory frameworks, including GMP, FDA QSR, and ISO 13485.
- Demonstrated experience with process validation, root cause analysis, data analysis, SPC, and corrective action implementation.
- Hands-on experience with titanium alloy (Ti-6Al-4V) additive manufacturing is a strong plus.
- Strong organizational, analytical, and problem-solving skills within a manufacturing setting.
- Proficiency in metrology and mechanical/metallurgical testing methods.
- Proven ability to lead cross-functional initiatives, influence stakeholders, and drive quality from concept to production.
- Excellent communication skills, with comfort engaging directly with suppliers and customers.
- Lean, Six Sigma, or similar continuous improvement certification is a plus.
