Quality Assurance ManagerSkills Alliance • Danbury, CT, US
Quality Assurance Manager
Skills Alliance • Danbury, CT, US
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionBachelor's degree in Engineering, Computer Science, Life Sciences, or a related field. 3–5+ years of experience in Quality Engineering, with direct involvement in medical device software development (diagnostics experience preferred). Strong knowledge of IEC 62304, ISO 13485, ISO 14971, and related regulatory frameworks. Hands-on experience with technical documentation, configuration management, change control, and risk management processes. Familiarity with software development methodologies (Agile / Scrum) and tools such as Jira, Confluence, and Git. Experience with electronic quality management systems (eQMS) is a plus. Excellent written communication, organisational, and collaborative skills. Ability to interpret regulatory requirements and apply them effectively within a development environment. Experience supporting regulatory submissions (FDA, CE marking). Certifications in Quality or Regulatory (e.g., ASQ CQE, RAPS) are advantageous. Familiarity with cybersecurity standards (e.g., FDA premarket guidance) is a plus.
About the Role – Quality Manager
We are looking for a detail-oriented, compliance-driven Quality Manager to help advance the development of our diagnostic medical device software while also supporting broader Quality Engineering and management responsibilities. This position plays a key role in ensuring our medical devices meet the highest standards of quality through strong documentation practices, structured development processes, and adherence to regulatory requirements.
Key Responsibilities
- Support Quality Management System activities and product development across software, mechanical, and electrical programs.
- Collaborate with software and medical device development teams to embed quality and regulatory requirements throughout the software development lifecycle and device development process.
- Define, implement, and maintain SOPs, work instructions, templates, and quality records for device and software design, development, and testing.
- Lead investigations, CAPA plans, and drive closure of customer complaints, nonconformances, and related issues.
- Oversee documentation control processes, ensuring accuracy, traceability, and compliance with regulations.
- Support the creation and upkeep of essential deliverables, including :
- Software Requirements Specifications
- Design History Files
- Risk Management Files (ISO 14971)
- Verification & Validation protocols and reports
- Requirements for testing traceability matrices
- Ensure compliance with IEC 62304, ISO 13485, ISO 14971, FDA 21 CFR 820, and other applicable standards.
- Partner with cross-functional teams (RA / QA, Operations, Engineering, R&D) to assess, audit, and continuously improve medical device and software development processes.
- Support internal and external audits, including remediation activities when required.
- Contribute to continuous improvement initiatives by identifying gaps and implementing practical solutions.
- Act as a quality advocate, offering guidance on documentation best practices to software, design, manufacturing, and other functional teams.
- Provide support across all aspects of Quality Engineering.
Qualifications
Preferred Qualifications
serp_jobs.job_alerts.create_a_job
Quality Assurance Manager • Danbury, CT, US
Job_description.internal_linking.related_jobs
Employment Type (Portal Display).We are seeking a forward-thinking Strategic QA Partner to lead and evolve our Quality Assurance practice into a proactive, business-aligned capability.This role goe...serp_jobs.internal_linking.show_more
We are looking for a Quality Assurance Manager to lead our Quality Management System and our quality team.In this key role, you'll be responsible for ensuring our quality standards are top-notch an...serp_jobs.internal_linking.show_more
Position Summary : The Quality Manager reports directly to the General Manager or Operations Manager, depending on the site.
This position also indirectly reports to the Global Quality Director for g...serp_jobs.internal_linking.show_more
The RTX Enterprise Services Organization is seeking a highly experienced technical integration manager skilled at understanding customer business problems, their application systems, and at identif...serp_jobs.internal_linking.show_more
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission.We're a growing pharm...serp_jobs.internal_linking.show_more
Lead and manage the Quality Assurance Department to ensure the production of high quality product at the lowest cost, while meeting the demands of our customers and ensuring the safety of our peopl...serp_jobs.internal_linking.show_more
We are seeking a motivated, career-focused individual to oversee and coordinate quality inspection activities, ensuring products meet design requirements.
This management position involves leading a...serp_jobs.internal_linking.show_more
Dymax, part of the Bachmann Chemical & Engineering family of brands, is based out of Torrington, Connecticut.Dymax is globally recognized as a pioneer in the development of light-curable adhesives ...serp_jobs.internal_linking.show_more
About the Role Quality Manager.We are looking for a detail-oriented, compliance-driven Quality Manager to help advance the development of our diagnostic medical device software while also supporti...serp_jobs.internal_linking.show_more
The Assurance Experienced Manager is responsible for supervising, directing, and reviewing the results through the delegation of tasks throughout the planning, field work and "wrap-up" stages of an...serp_jobs.internal_linking.show_more
Location : Bridgeport, CT, US, 06610-0156.Business Unit : Paragon Medical Advanced Surgical.Paragon Medical, a business of AMETEK, is a trusted partner in medical device manufacturing, offering end-t...serp_jobs.internal_linking.show_more
Nesco Resource is in search of a Quality Manager to work for one of our clients based in Shelton, CT.Overall responsibility for managing the Quality department in order to establish advanced qualit...serp_jobs.internal_linking.show_more
The Quality Manager (Automotive) will : .Lead and manage the quality team, including engineers, technicians, inspectors, and second-shift staff.
Oversee all quality assurance activities across product...serp_jobs.internal_linking.show_more
The Quality Auditor at Alexion Rare Disease Unit (ARDU) has key responsibilities for auditing a variety of GMP / GDP sites (internal and external suppliers) used in commercial and development project...serp_jobs.internal_linking.show_more
Quality Assurance Engineer – Medical Device Manufacturing (Onsite | Watertown, CT).Are you ready to take on a hands-on quality leadership role in a highly regulated, fast-paced manufacturing enviro...serp_jobs.internal_linking.show_more
Are you ready to build your career by joining Utilities Solutions Company? If so, our client is hiring a Quality Assurance Manager.
Position Type : Direct Hire Hybrid Required : Must have minimum 710 ...serp_jobs.internal_linking.show_more My client is a precision manufacturer specializing in metal components and assemblies for industries such as automotive, electrical, and medical devices.
Their capabilities include various metal sta...serp_jobs.internal_linking.show_more 
Challenge Yourself and Impact the Future!.MacDermid Alpha Electronic Solutions, a business of Element Solutions Inc (NYSE : ESI), is renowned worldwide for it's commitment to revolutionizing the...serp_jobs.internal_linking.show_more
About the Role – Quality Manager.We are looking for a detail-oriented, compliance-driven Quality Manager to help advance the development of our diagnostic medical device software while also support...serp_jobs.internal_linking.show_more
Lead and manage the Quality Assurance Department to ensure the production of high quality product at the lowest cost, while meeting the demands of our customers and ensuring the safety of our peopl...serp_jobs.internal_linking.show_more
Manager, Quality Assurance
Atlas Air • White Plains, NY, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Quality Assurance Manager
Randstad • Ansonia, CT, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Quality Manager
TransPak • Trumbull, CT, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Quality Systems Integration Manager
Raytheon • Unionville, CT, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Director, Clinical Quality Assurance
Eisai • Bridgeport, CT, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Quality Assurance Manager
Liberty Coca-Cola Beverages • Elmsford, NY, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Quality Assurance Manager
PrideStaff • Bristol, CT, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Senior Quality Manager
Bachmann Chemical & Engineering • Torrington, CT, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Quality Assurance Manager (Danbury)
Skills Alliance • Danbury, CT, US
serp_jobs.job_card.part_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Assurance Experienced Manager
BDO USA • Stamford, CT, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Job Senior Manager, Quality
Ametek • Bridgeport, CT, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Quality Manager
Nesco Resource • Shelton, CT, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Quality Manager - Automotive - Bristol,CT
Michael Page • Bristol, CT, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Senior Manager, Global Operations Audit - Quality
Alexion Pharmaceuticals • New Haven, CT, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Quality Assurance Engineer
EPS Connects LLC • Watertown, CT, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Quality Assurance Manager
Hired by Matrix • Port Chester, NY, US
serp_jobs.job_card.permanent
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Quality Manager- Automotive- Bristol, CT
Michael Page • Bristol, CT, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Quality Assurance Specialist
Element Solutions • West Haven, CT, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
Quality Assurance Manager
Skills Alliance • Danbury, CT, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Quality Assurance Manager (Elmsford)
Liberty Coca-Cola Beverages • Elmsford, NY, US
serp_jobs.job_card.part_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted