Sr. Quality Assurance Engineer

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 treatment response. Akoya offers the PhenoCycler® and PhenoImager® platforms to serve the diverse needs of researchers across discovery, translational and clinical research.

Position Summary/Impact:

This position is a key member of the Quality team, primarily supporting Akoya’s companion diagnostic (CDx) development programs. This individual will interact with a variety of functions across Akoya Biosciences’ growing sustaining product and new product development environments as well as operations, working directly with Quality Management, product development, software development, manufacturing, operations, sustaining engineering, product- and program- management as well as other groups to ensure compliance to Akoya’s Product Development Process (PDP) and according to ISO 13485, IEC62034, ISO14971, and other medical device quality requirements. This individual must be able to work independently and on teams to guide the development process, and investigate, resolve or escalate quality issues in a collaborative, and timely manner. Core values must include commitment to customer and operations excellence with demonstrated ethics and integrity.

The Sr. Quality Assurance Engineer will provide leadership and input to new product development teams in the design of complex diagnostic instruments and devices. The candidate will ensure compliance to design control requirements, customer requirements, and standards and regulations are maintained throughout the IVD product lifecycle. This individual will also be responsible for DHF assembly, Product Risk Management- quality- and design control requirements as a member of the product/project teams and help in ensuring the successful transfer of the product design to manufacturing. They are responsible for maintenance, updates and evaluation of the DHF deliverables in the QMS, as well as participating as an active member of the Quality team in maintaining the quality system functions. Play an active and key role in all quality system functions within Akoya’s Quality Management System, including day-to-day QMS processes such as Design Control, Document and Change Control, Training, CAPA/NC, material management and qualification, MRB and KPI metrics as needed. This individual will also help improve and develop new processes as the QMS grows and expands.

Duties & Responsibilities:

• Support Design Quality as needed for hardware, associated software and reagents.
• Participate as the primary SME on instrument/equipment/assay/device New Product Development projects related to Akoya’s companion diagnostic program.
• Participate as the primary Quality SME for software development reviews and confirmation of compliance to IEC 62304.
• 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.
• Collaborate in the development and maintenance of product DHF documentation; ensure correct participants execute any changes in their area of responsibility and document updates to DHF quality records accordingly.
• Provide day-to-day support for Document and Change Control in the electronic QMS including processing change orders, training new users on the Change Control process, and serving as an electronic QMS subject matter expert.
• Support Supplier quality processes for instruments in the eQMS such as supplier evaluation/qualification and performance monitoring (in conjunction with Supplier Quality).
• Support operations with general quality issues and review of DHRs and Batch Records
• Participate and drive continuous improvement QMS processes such as Non-conformance, CAPA, Internal Audits, and Complaints/complaint investigation in the electronic QMS, with the appropriate counterparts.
• Participate in design, process, and user Risk Management and analysis.
• Support external audits, including customer and ISO audits as well as FDA inspections.
• Champion Quality processes and compliance; serve as a Quality resource for other departments.
• Perform other duties as assigned.

Qualifications/Skills:

• 5+ years of Quality Assurance experience in an ISO 13485 or FDA regulated medical device organization.
• Bachelor’s Degree in Chemistry, Biology, Engineering, or a related field or equivalent experience.
  
• Experience in Document or Change Control is preferred.
• Proven knowledge in ISO 13485 and medical device Quality Management Systems
• Proven knowledge of IEC 62304
• 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 based on ISO 14971 with R&D, Software Development, Project Management and Manufacturing
• Flourishes in a highly dynamic and small company environment
• Ability to work both individually and in a team environment and to meet deadlines.
• Computer proficiency and ability to use complex electronic QMS or business systems.
• Ability to work on-site as needed, however this role can be primarily hybrid/remote based.

The hiring range for this position is $93,000 to $123,000 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.