Manager, Quality Engineering

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:

Akoya Biosciences is looking for a Manager of Quality Engineering to join our Quality team. Reporting to the VP, Quality Assurance and Regulatory Affairs, this individual will manage a variety of quality system functions of Akoya Biosciences’ growing Quality Management System (QMS), working with quality assurance, product development, manufacturing, supply chain, CMOs, 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 Manager will be responsible for day-to-day QMS processes such as monitoring & measuring supplier performance, auditing, quality engineering, validation planning, change control, CAPA, complaint & non-conformance investigations, and design quality. The individual will also help to develop new processes as the QMS grows and will have opportunities to grow within the Quality group.

Duties & Responsibilities:

• Provide expertise and general oversight for the management and improvement of Akoya Biosciences’ Quality Systems, including quality planning, quality control planning, inspection procedures, supplier quality, document controls, change management, process controls, quality records, corrective and preventive activities, validations, customer complaint investigations, and data management.
• Oversee Contract Manufacturing relationships related to supplier quality monitoring and evaluations.
• Implement Quality Systems improvements.
• Prepare and review Change Orders (CO) and Deviations for operating procedures and operating instructions.
• Format, manage and maintain Quality Plans and PFMEAs for new products to ensure that Quality Requirements are in place when new products are introduced into Manufacturing.
• Drive Quality Planning activities in support of new product launches and Quality System improvement.
• Analyze data to identify trends and drive continual improvement projects.
• Review and analyze specifications relating to acceptance activities. Monitor and report quality.
• Generate and review Validation Protocols and Reports (IQ, OQ, PQ) for adequacy, completeness, and compliance with Quality Systems requirements. Ensure that validation activities are appropriate to their needs and in alignment with the Akoya Biosciences’ priorities.
• Perform and assist with investigations) for customer complaints and/or deficiencies identified internally.
• Participate in problem-solving activities to determine root cause and effective corrective action.
• Review and approve first article inspections as needed.
• Develop and/or revise incoming spec documentation.
• Provide general oversight and training on Quality procedures and practices.
• Assist management with improving Quality Systems and increasing compliance with appropriate regulations.
• Other duties as assigned.

Qualifications/Skills:

• Bachelor’s Degree in Engineering or technical discipline
• 7-10 years Medical Device/IVD Experience as a Quality Engineer / Supply Quality Engineer with noticeable increase in roles and responsibilities, combined with 1-3 years leading or supervising an Engineering team within a FDA regulated reagents, medical device or IVD manufacturing company
• Proven knowledge of ISO 13485:2016 and 21CFR820
• Detail-oriented, able to read and interpret technical documents.
• Ability to exercise judgement in selecting methods and techniques for obtaining results.
• Excellent attention to detail
• Experience working directly with suppliers on in a quality function.
• Strong organizational, writing, and oral communication skills
• Flourishes in a highly dynamic and small company environment
• Ability to multi-task and complete work independently
• 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.
• Statistical Software experience a plus
• Previous experience working with Arena and/or Power BI a plus.
• Will require travel to supplier sites (10-20%)

The hiring range for this position is $110,000 to $150,000 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.