Principal Quality Engineer

Principal Quality Engineer at ClinLab Solutions Group Principal Quality Engineer at ClinLab Solutions Group in Ayer, Massachusetts Posted in about 22 hours ago.

Type:

full-time

Job Description:

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.