We are seeking a highly skilled and motivated Quality Engineer, specializing in design assurance, to join our Quality Assurance team. The ideal candidate will have extensive experience in the medical device industry, preferably within In Vitro Diagnostics (IVD) and supporting analytical software. The Quality Engineer will play a critical role in ensuring our products meet the highest standards of quality, safety, and regulatory compliance, by overseeing and contributing to the verification and validation, and design transfer processes for our IVD and RUO Assays and Analytical software.
This role will also help implement and maintain the Pillar Quality Management System, by contributing to the CAPA, NCMR, Deviation, and audit processes.
Duties and Responsibilities

• Develop, implement, and maintain quality assurance processes and systems to ensure compliance with FDA, ISO 13485, and other regulatory requirements.
• Oversee and contribute to verification and validation activities, and design transfer activities.
• Participate in design and development reviews to ensure quality and regulatory requirements are met.
• Lead root cause analysis and corrective/preventive actions (CAPA) for non-conformances and customer complaints for software design issues.
• Assist in performing internal audits and coordinating external audits, ensuring timely closure of audit findings.
• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Collaborate with cross-functional teams including R&D, manufacturing, and regulatory affairs to ensure quality considerations are integrated throughout the product lifecycle.
• Prepare and review documentation for software verification and validation activities and design transfer.
• Monitor and analyze quality metrics to identify trends and drive continuous improvement initiatives.
• Provide training and support to staff on quality systems, regulatory requirements, and best practices.

Qualifications

• Requires B.S. in Biology, Molecular Biology, Genetics, Computer Science or related field, or equivalent work experience.
Experience:

• Knowledgeable in ISO 13485:2016, IEC 62304, ISO 14971, 21 CFR Part 11 and 820, and the EU's IVDR.
• Strong document and technical writing skills
• Experience in product development and design transfers in the medical device industry
• Prior software quality assurance experience in the medical device field is preferred
• Experience in validating software systems
Knowledge, Skills, and Abilities:

• Excellent analytical skills.
• Strong interpersonal skills with ability to work both independently and as part of a team.
• Excellent written and verbal communication skills.
• Proficient with Microsoft Office (Word, Excel, PowerPoint)
• Strong attention to detail and accuracy. Ability to successfully balance and prioritize multiple ongoing projects/tasks (Project Management skills).

Working Conditions

• This position is conducted in a mix of a standard lab and office environment. Must be able to perform work while sitting or standing for long periods of time.
• Position may at times require repetitive movements. Must be able to lift, push, pull and carry up to 25 lbs.
• This is a hybrid position based in Natick, MA with an expectation of 3 days in the office and 2 days working remotely.

Pillar Biosciences aims to "Make precision medicine the first option for every patient" by developing and manufacturing targeted next-generation sequencing (NGS)-based assays and software for today's high-throughput specialty NGS laboratories. We are seeking collaborative and independent problem solvers to support our mission.
Pillar Biosciences is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; religion; age; nationality; marital status; sexual orientation; disability or any other characteristic protected by law.