About Akoya Biosciences:As The Spatial Biology Company®, Akoya Biosciences’ mission is to bring context to the world of biology and human health through the power of spatial phenotyping. The company offers comprehensive single-cell imaging solutions that allow researchers to phenotype cells with spatial context and visualize how they organize and interact to influence disease progression and response to therapy. Akoya offers a full continuum of spatial phenotyping solutions to serve the diverse needs of researchers across discovery, translational and clinical research: PhenoCode™ Panels and PhenoCycler®, PhenoImager® Fusion, and PhenoImager HT Instruments.

Job Description Summary:

Akoya Biosciences is looking for a Quality Engineer to join our Quality team. The individual will support a variety of quality system functions in Akoya Biosciences’ growing Quality Management System (QMS), all related to Akoya’s complex instrumentation. The individual will work with Quality Management, Product Development, Manufacturing, Supply Chain, and other groups, to ensure compliance to ISO 13485 and medical device quality requirements. The individual must be able to work independently and resolve or escalate quality issues in a creative, collaborative, and timely manner. Core values must include commitment to customer and operations excellence with demonstrated ethics and integrity. The Quality Engineer will support day-to-day QMS processes such as Document Control, Change Control, CAPA, Complaint & Nonconformance investigations, monitoring & measuring supplier performance, auditing, and design quality. The individual will also help develop new processes as the QMS grows and will have opportunities to grow within the quality group.

Duties & Responsibilities:

• Provide day-to-day support for Document and Change Control in the electronic QMS, including processing change orders.

• Participate in and drive continuous improvement for QMS processes such as Nonconformance, CAPA, Internal Audits, and Complaint investigation in the electronic QMS.
• Support Supplier quality processes for RUO instruments such as evaluating/qualifying new and existing suppliers, performing supplier audits, and monitoring supplier performance.
• Maintain supplier files and Akoya’s Approved Supplier List.

• Support the review of product design control and design quality documentation.
• Participate in design, process, and user FMEA analysis.

• Participate as the primary SME on RUO instrument/equipment/device New Product Development projects as well as sustaining projects.
• Build and maintain key quality deliverables for projects including risk management files, quality plans, inspection plans, SOP’s, and other quality records related to product design.
• Maintain product DHF documentation; ensure correct participants execute any changes in their area of responsibility and document updates to DHF quality records accordingly.

• Support operations with general quality issues and review of device history records.
• Support external audits, including the preparation for ISO certification.

• Prepare metrics for routine reporting and Operations / Management Review.
• Champion Quality processes and compliance; serve as a Quality resource for other departments.

• Perform other duties as assigned.

Qualifications / Skilla:

• 3-5 years of Quality Assurance experience in an ISO 13485 or medical device organization
• Experience with electro-mechanical systems preferred
• Bachelor’s degree in engineering or technical discipline, or the equivalent combination of education, experience and/or training
• Experience in Document or Change Control is preferred.
• Proven knowledge in ISO 13485 and medical device Quality Management Systems
• Excellent attention to detail
• Strong organizational, writing, and oral communication skills
• Ability to multi-task and manage priorities.
• Experience leading/participating in Risk/FMEA analysis with R&D and Manufacturing
• Flourishes in a highly dynamic and small company environment
• Ability to work in a team environment and to meet deadlines.
• Computer proficiency and ability to use complex electronic QMS or business systems.
• ASQ certifications of CQE and CQA are a plus.
• Will require travel to supplier sites (10-20%)

The hiring range for this position is $75,000 - $97,000 per year, which may factor in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors. Our full-time regular positions also include an annual performance-based bonus (or a sales incentive plan) and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the level and position offered.

Akoya’s excellent benefits program includes a selection of Medical and Dental plans, and Life, AD&D and Short-Term Disability insurance, Tuition Reimbursement, 401(k) with immediate Company match vesting, Company paid holidays and more!

Akoya values bringing together individuals with diverse backgrounds. We are proud to be an Equal Opportunity/Affirmative Action Employer. We do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.