Quality Assurance Manager

About Akoya Biosciences, Inc.

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 seeking a dynamic and energetic person to fill the role of Manager, Quality Assurance with primary responsibilities of the development, management, and oversight of the Quality Management System including Document Control, Post Market Surveillance, CAPAs, Nonconforming Materials, Audits, Compliance, and Training. This position is based at the Marlborough MA, Donald Lynch Boulevard location. As an integral member of our Quality Management team, you will be responsible for driving continuous improvement of the Quality System and championing the importance of Quality throughout the organization.

Monitors the Quality System standards and regulations to identify new or revised requirements and conducts gap analyses where appropriate to determine impact to Akoya’s Quality Management System. Drive the development of metrics for all areas of the QMS, and report results of the metrics to Management Reviews. Interact directly with management regarding QMS compliance and the monitoring of the systems and processes.

Duties and Responsibilities

• Front Room direct support during External Audits
• Support internal audits of Akoya’s Quality System
• CAPA Management of internal and external CAPAs for appropriate action, risk assessment and effectivity
• Oversee employee training, including development QMS content driven training programs
• Act as a cultural change agent championing the vision of Quality throughout the organization
• Responsible for Akoya’s post market surveillance program
• Provide quality oversight on company improvement projects, and new product integration (NPI) programs
• Ensure compliance to company procedures and processes
• Quality Planning – developing and executing plans related to QMS improvements
• Oversee metrics and KPI’ s for evaluation and reporting at Management Reviews
• Ensure timely response and feedback to Akoya’s customers as it relates to post market activities
• Responsible for maintaining and controlling Akoya’s documents of external origin
• Perform gap analysis to Akoya’s QMS when new or revised documents of external origin are released
• Measure, monitor, and report metrics on all the systems listed above to ensure system effectiveness and efficiency and implement updates/changes as necessary to meet changing business needs
• Collaborate with department/system SMEs to develop new QMS metrics to monitor the health of the QMS
• Collaborate with department/system SMEs to develop and/or revise existing procedures instructions to ensure documentation is compliant to internal QMS requirements and external regulatory requirements
• Assist in the development and validation of software related to the quality management system
• Other duties as assigned

Qualifications/Skills

• BS Degree in the Sciences or other technical discipline, or 7-plus years of QA experience in the medical device or diagnostic industry, or the equivalent combination of education, experience and/or training
• Minimum of 3 years directly managing a QA and/or Quality System department

• Knowledge of national and international regulations applicable to medical devices including Quality System Regulations, 21 CFR 820, 21 CFR 803 and 804, 806, 809, Canadian Medical Device Regulations, ISO 14971, ISO 13485, IVDR/MDR
• Skilled at performing and leading internal and external audits
• Proven track record leading and executing process improvements
• Strong communication and presentation skills
• Demonstrate ability to apply Root Cause Analysis tools and structured problem-solving methodologies to QMS issues

• Prior experience overseeing a web/cloud-based PLM/eQMS platforms, Arena PLM preferred including experience in eDMS validations
• Effective organizational and time management and the ability to work towards multiple priorities while delivering quality outcomes
• Excellent verbal and written communication skills, including attention to detail; strong questioning and listening skills
• Foster the development of a high performing team, managing performance of team members with varying levels of skill and experience, and mentoring high potential individuals to achieve greater impact on the organization in the transformation to a true culture of Quality
• Relevant application, fileshare, and organizational collaboration tools experience (i.e., MS Office 365, MS Teams/SharePoint, SalesForce, Adobe Creative Cloud, etc.)
• Awareness and familiarity with ERP & PLM system architecture and manufacturing documentation (e.g., item/part, BOM, MPN, etc.) with regular usage in prior roles
• Ability to think critically and demonstrate troubleshooting and problem-solving skills
• Certified Quality Auditor and/or Certified Quality Manager through ASQ is a plus

The hiring range for this position is $115,000 - $152,000 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.