Senior Clinical Quality Assurance Director
1 week ago
The Senior Clinical Quality Assurance Manager leads the Clinical Quality team for the Endoscopy and Urology divisions. They develop divisional strategies and goals aligned with the global CQA management team. Additionally, they collaborate with clinical trial teams to ensure clinical research activities comply with federal and international regulations as well as Boston Scientific procedures and expectations.
Key Responsibilities:- Collaborates with Clinical leadership in embedding and sustaining a culture of quality.
- Collaborates with Clinical leadership to understand needs and establish priorities.
- Collaborates with Global Clinical Quality teams to continually identify opportunities for improvement.
- Acts as a subject matter expert relative to the interpretation of regulations and their implementation.
- Identifies key areas of regulatory risk and resolutions.
- Identifies ways to improve compliance with regulations and BSC policies and procedures.
- Participates in the development, implementation, and maintenance of global quality systems.
- Oversees management of the clinical audit program.
- Analyzes audit findings for trends and provides clinical leadership with regular reports and recommendations.
- Provides data for, and participates in, management review.
- As needed, assists with internal and external audits (internal systems, trial master file, investigator sites, clinical service providers) to assess the accuracy and quality of scientific data collected, and to determine the level of compliance with applicable regulations.
- Reviews audit reports for accuracy and consistency.
- Provides oversight of Clinical CAPA activity.
- Reviews SOPs to assure compliance with regulations and BSC policies and procedures.
- Provides input to training function and, where appropriate, gives training on issues identified during audits.
- Supports the preparation, coordination, and management of regulatory agency inspections of BSC offices. During inspection, plays lead role as facilitator and communicator.
- Prepares investigator sites for FDA or other regulatory agency inspections and assists in preparation of written responses to findings.
- Keeps abreast of regulatory requirements, and updates management on the possible ramifications of regulatory changes.
- Will lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports (auditors and analysts), and drive those practices throughout their organization.
- Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
- May direct and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations.
- Monitors and ensures compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
- Bachelor's degree and 5+ years of Clinical Quality or related experience.
- 5+ years of direct or indirect management experience.
- Subject Matter Expert of FDA, ISO and other associated regulations pertaining to Clinical Study activity.
- Experience working with audits & inspections.
- Clinical site and vendor management experience.
- Demonstrated proficiency in staff leadership and development.
- Strong leadership competencies - particularly communication, collaboration, planning, innovation, and strategic thinking.
- Advanced degree.
-
Senior Quality Assurance Manager
2 weeks ago
Marlborough, Massachusetts, United States SMART TECH SKILLS LLC Full timeJob OverviewWe are seeking a Senior Quality Assurance Manager to lead our quality assurance efforts at Smart Tech Skills LLC. This role is crucial in ensuring the delivery of high-quality software solutions.Key Qualifications:Over 10 years of experience in large-scale program implementations and Quality Assurance.Proven track record in a leadership...
-
Senior Quality Assurance Specialist
2 weeks ago
Marlborough, Massachusetts, United States Boston Scientific Full timeAdditional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we provide an environment where you can leverage your full potential by collaborating with a diverse and high-achieving workforce, addressing critical challenges in the healthcare sector. With access to cutting-edge...
-
Senior Quality Assurance Engineer
2 weeks ago
Marlborough, Massachusetts, United States Boston Scientific Full timeAdditional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we provide a platform for you to leverage your full potential by collaborating with a diverse and high-achieving workforce, addressing some of the most significant challenges in the healthcare sector. With access to...
-
Marlborough, Massachusetts, United States ECI Full timeAbout the RoleECI is seeking a highly skilled Senior Software Design Quality Assurance Engineer to join our team. As a key member of our quality assurance team, you will play a pivotal role in ensuring the highest quality and compliance of software systems used in medical devices.Key ResponsibilitiesLead Quality Assurance Projects: Collaborate with Product...
-
Quality Assurance Inspector
1 week ago
Marlborough, Massachusetts, United States Complete Staffing Solutions, Inc. Full timeJob OverviewQuality Assurance InspectorCompany: Complete Staffing Solutions, Inc.This role offers a fantastic opportunity to contribute to a reputable organization.Work Schedule:Full Time – Temporary to Permanent PositionMonday to Friday, 7:00 AM to 3:30 PMKey Responsibilities:Conduct inspections of materials, components, and finished goods to verify...
-
Quality Assurance Laboratory Supervisor
2 weeks ago
Marlborough, Massachusetts, United States Defense Contract Manufacturing Co. Full timeJob OverviewPosition Summary: As the Quality Assurance Laboratory Supervisor, you will be pivotal in upholding our dedication to superior quality. You will manage a skilled group of Quality Technicians and Mechanical Inspectors, ensuring that all products adhere to stringent quality benchmarks while actively contributing to the enhancement of our operational...
-
Quality Assurance Specialist
6 days ago
Marlborough, Massachusetts, United States IPG Photonics Full timeJob DescriptionAt IPG Photonics, we are seeking a highly skilled Quality Control Technician to join our team. As a Quality Control Technician, you will play a critical role in ensuring that our products meet the highest standards of quality and safety.Key Responsibilities:Conduct Quality Control Inspections: Use precision measuring tools and equipment to...
-
Clinical Operations Director
7 days ago
Marlborough, Massachusetts, United States Planet Pharma Full timePosition: Director of Clinical OperationsAs the Director of Clinical Operations, you will oversee a dedicated team of approximately 80 clinical professionals based in the United States. Your primary responsibilities will include:Evaluating and enhancing performance metrics across the division.Optimizing workforce efficiency and implementing necessary...
-
Quality Assurance Specialist III
5 days ago
Marlborough, Massachusetts, United States Boston Scientific Full timeAbout the Role:The CIS Quality Assurance Specialist III is responsible for day-to-day activities related to returned complaint products. This individual will assist and support Engineers who perform in-depth complaint analysis and investigations, including root cause analysis, returned product analysis, and investigation closure for BSC manufactured and OEM...
-
Clinical Operations Director
7 days ago
Marlborough, Massachusetts, United States Planet Pharma Full timePosition: Director of Clinical OperationsAs the Director of Clinical Operations, you will oversee a dedicated team of approximately 80 clinical professionals based in the United States. Your primary responsibilities will include:Performance Evaluation: Assessing and enhancing the performance metrics across the division.Workforce Optimization: Streamlining...
-
Clinical Operations Director
7 days ago
Marlborough, Massachusetts, United States Planet Pharma Full timePosition: Director of Clinical OperationsAs the Director of Clinical Operations, you will oversee a dedicated team of approximately 80 clinical professionals across the United States. Your primary responsibilities will include:Performance Review: Conducting thorough evaluations of team performance across the division.Workforce Optimization: Streamlining...
-
Clinical Operations Director
7 days ago
Marlborough, Massachusetts, United States Planet Pharma Full timePosition: Director of Clinical OperationsAs the Director of Clinical Operations, you will oversee a dedicated team of approximately 80 clinical professionals across the United States. Your primary responsibilities will include:Performance Review: Assessing and enhancing the performance metrics across the division.Workforce Optimization: Streamlining the...
-
Lead Quality Assurance Engineer
2 weeks ago
Marlborough, Massachusetts, United States Allegro MicroSystems Full timeThe Allegro team is dedicated to delivering innovative solutions that advance the world towards a safer and more sustainable future. With over three decades of expertise in developing cutting-edge semiconductor technology, our commitment to purposeful innovation influences every facet of our operations. From engaging with customers and recognizing employee...
-
Quality Assurance Inspector
2 weeks ago
Marlborough, Massachusetts, United States Complete Staffing Full timePosition:Quality Control InspectorCompany:Complete StaffingJob Overview:This role involves ensuring that materials, components, and finished goods meet established quality standards. The Quality Control Inspector will conduct comprehensive evaluations of incoming materials, in-process items, and final products to verify adherence to specifications and...
-
Quality Assurance Inspector
2 weeks ago
Marlborough, Massachusetts, United States Complete Staffing Full timePosition:Quality Control InspectorCompany:Complete StaffingOverview:We are seeking a dedicated Quality Control Inspector to ensure that our products meet the highest standards of quality and compliance. This role involves meticulous inspection of materials and finished goods to uphold our commitment to excellence.Key Responsibilities:1. Conduct comprehensive...
-
Quality Assurance Inspector
2 weeks ago
Marlborough, Massachusetts, United States Complete Staffing Full timePosition:Quality Control InspectorLocation:Marlborough, MACompany:Complete StaffingWork Schedule:Full Time – Temp to HireMonday – Friday, 7:00am – 3:30pmKey Responsibilities:As a Quality Control Inspector, you will be tasked with the following:1. Conducting detailed inspections of materials, components, and finished goods to ensure adherence to...
-
Quality Assurance Specialist
2 days ago
Marlborough, Massachusetts, United States ZephyrTech Full timeAbout ZephyrTechZephyrTech is a dynamic and technology-driven company committed to sustainability and innovation. As a family-owned business, we value long-term relationships and career advancement opportunities.Job SummaryWe are seeking a Quality Management Employee to join our team. The successful candidate will be responsible for ensuring the quality of...
-
Quality Assurance Specialist
1 day ago
Marlborough, Massachusetts, United States Randstad North America, Inc. Full timeAbout the RoleWe are seeking a highly skilled Quality Control Scientist to join our team at Randstad North America, Inc.Key Responsibilities:Develop and implement quality control processes to ensure compliance with regulatory requirementsCollaborate with cross-functional teams to identify and implement process improvementsAnalyze data to identify trends and...
-
Quality Assurance Specialist
1 day ago
Marlborough, Massachusetts, United States Randstad Life Sciences US Full timeJob SummaryThe Quality Control Scientist I Analytical will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within Quality Control, and identifying and implementing continuous improvement initiatives related to overall laboratory...
-
Marlborough, Massachusetts, United States Allegro MicroSystems Full timeJoin the Allegro MicroSystems Team At Allegro MicroSystems, we are dedicated to delivering innovative solutions that contribute to a safer and more sustainable world. With over three decades of expertise in advanced semiconductor technology, we are committed to excellence in quality assurance. Role Overview As a Senior Customer Quality Engineer, you will...