Sr Quality Assurance Manager
3 weeks ago
Position Overview:
Brunel is seeking a highly skilled and experienced Senior Manager of Quality Assurance to join our MA-based client. The Senior Manager of Quality Assurance will be responsible for overseeing all aspects of quality assurance activities related to the design, development, manufacturing, and distribution of their Class II medical devices. This role requires strong leadership abilities, exceptional attention to detail, and a deep understanding of regulatory requirements in the medical device industry.
Key Responsibilities:
Develop and maintain the company's quality management system (QMS) in compliance with relevant regulations and standards, including FDA QSR (21 CFR Part 820) and ISO 13485.
Lead and mentor a team of quality assurance professionals, providing guidance and support to ensure the highest level of quality and compliance across all departments.
Establish and maintain quality objectives and key performance indicators (KPIs) to monitor and improve the effectiveness of the QMS.
Coordinate internal and external audits, including FDA inspections and Notified Body audits, and ensure timely resolution of any findings or observations.
Oversee the review and approval of design control documents, including design inputs, design outputs, verification and validation activities, and risk management documentation.
Collaborate with cross-functional teams to ensure quality and compliance requirements are considered throughout the product lifecycle, from concept to commercialization.
Drive continuous improvement initiatives to enhance quality processes, reduce non-conformances, and optimize efficiency within the organization.
Serve as the primary point of contact for quality-related communications with regulatory agencies, customers, and suppliers.
Stay informed about changes in regulations, standards, and industry best practices, and implement necessary updates to the QMS accordingly.
Represent the quality assurance function in management meetings, providing updates on quality performance and addressing any issues or concerns.
Qualifications:
Bachelor's degree in engineering, life sciences, or related field; advanced degree preferred.
Minimum of 7+ years of experience in quality assurance roles within the medical device industry, with a focus on Class II devices.
In-depth knowledge of FDA regulations (21 CFR Part 820) and ISO 13485 quality management system requirements.
Strong leadership and team-building skills, with the ability to inspire and motivate a diverse team of professionals.
Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders.
Proven track record of successfully managing regulatory inspections and audits.
Experience with risk management methodologies, such as ISO 14971, and familiarity with design control processes.
Quality certifications (e.g., ASQ Certified Manager of Quality/Organizational Excellence, ASQ Certified Quality Auditor) are a plus.
#J-18808-Ljbffr
-
Sr Manager, GCP Quality Assurance
6 days ago
Oklahoma City, United States Morphic Therapeutic Full timeDescription About Morphic Therapeutic Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with Schrödinger, Morphic is advancing its pipeline and discovery...
-
SR Quality Assurance
3 weeks ago
Jersey City, United States PMG GLOBAL Full timeWe are currently sourcing for an "SR Quality Assurance / Automation Engineer" to work at our client's location in Jersey City-NJ.The Expertise and Skills You BringBachelor’s degree in computer science or related field required.5+ years of Software Quality Engineering experience.Hands on experience in developing and maintaining automation test suites using...
-
SR Quality Assurance
3 weeks ago
Jersey City, United States PMG GLOBAL Full timeWe are currently sourcing for an "SR Quality Assurance / Automation Engineer" to work at our client's location in Jersey City-NJ.The Expertise and Skills You BringBachelor’s degree in computer science or related field required.5+ years of Software Quality Engineering experience.Hands on experience in developing and maintaining automation test suites using...
-
Associate Director of Quality Assurance
3 weeks ago
Oklahoma City, United States ProtaGene US, Inc Full timeAssociate Director of Quality Assurance (GCP/GLP) Massachusetts , United States Massachusetts , United States ProtaGene is a world leading analytical CRO partner for the global biopharmaceutical, gene, and cell therapy industries. From research support through product CMC characterization, clinical testing, and post-market release lifecycle management and...
-
SR Quality Assurance
5 days ago
Jersey City, United States PMG Global Full timeWe are currently sourcing for an "SR Quality Assurance / Automation Engineer" to work at our client's location in Jersey City-NJ. Find out more about the daily tasks, overall responsibilities, and required experience for this opportunity by scrolling down now. The Expertise and Skills You Bring Bachelor’s degree in computer science or related field...
-
Quality Assurance Manager
7 days ago
Kansas City, United States EPM Scientific Full timeQuality Assurance Manager Location: Kansas City, MO Working Situation: Onsite Level: Manager We are currently seeking a talented and experienced Quality Assurance Manager to join our team in Kansas City, MO. We are a global biotechnology company focusing on human and animal tissues, cell products, and other biofluids. This permanent position offers an...
-
Quality Assurance Manager
2 weeks ago
Arizona City, United States Pop-Up Talent Full timeQuality Assurance Manager Mesa, AZ 85212 JOB SUMMARY: The Manager of Quality Assurance will be responsible for all Quality aspect of our products and developing the Manufacturing team. There will be heavy focus on employee development, safety, process, training and maintaining production schedules to meet production goals and company objectives. The Quality...
-
Quality Assurance Tester
17 hours ago
Oklahoma City, United States Inceed Full timeCompensation: $25-$27/hourly Location: Oklahoma City, OK Quality Assurance Tester Inceed has partnered with a great company to help find a skilled Quality Assurance Tester to join their team! Responsibilities: Assess software quality though manual and automated testing Conduct tests and analyze results Work with developers to share perspective of testing...
-
Quality Assurance Manager
7 days ago
Bay City, United States Tenaris Full timeQuality Assurance Manager - Bay City, TX*Entity/Department: Tenaris Bay City Inc.Location: Bay City, TXMAIN RESPONSIBILITES: Coordinates Quality Assurance activities, e.g. development of local documents, management of Quality events (customer claims/dissatisfaction, non-conformities, improvement actions). Develops and updates the necessary procedures,...
-
Senior Manager, Quality Assurance
1 week ago
Foster City, California, United States Gilead Sciences, Inc. Full timeFor Current Gilead Employees and Contractors:Please log onto your Internal Career Site $) to apply for this job.At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access...
-
Quality Assurance Manager
1 day ago
Earth City, United States Deutsche Precision, LLC Full timeEssential Job Functions: include the following. Other duties may be assigned.Plans and conducts the analysis, inspection, design, tests, and/or integration to assure the quality of assigned product or component.Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.Ensures all purchased...
-
Quality Assurance Manager
1 day ago
Earth City, United States Deutsche Precision, LLC Full timeJob DescriptionJob DescriptionEssential Job Functions: include the following. Other duties may be assigned.Plans and conducts the analysis, inspection, design, tests, and/or integration to assure the quality of assigned product or component.Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process...
-
Quality Assurance Manager
11 hours ago
Bay City, United States Tenaris Full timeQuality Assurance Manager - Bay City, TX* Entity/Department: Tenaris Bay City Inc. Location: Bay City, TX MAIN RESPONSIBILITES: Coordinates Quality Assurance activities, e.g. development of local documents, management of Quality events (customer claims/dissatisfaction, non-conformities, improvement actions). Develops and updates the necessary procedures,...
-
Quality Assurance Manager
6 days ago
Panama City, Florida, United States Tenaris Full timeQuality Assurance Manager - Bay City, TX* Entity/Department: Tenaris Bay City Inc.Location: Bay City, TX MAIN RESPONSIBILITES:Coordinates Quality Assurance activities, e.g. development of local documents, management of Quality events (customer claims/dissatisfaction, non-conformities, improvement actions). Develops and updates the necessary procedures,...
-
Quality Assurance Manager
5 days ago
Bay City, United States Tenaris Full timeQuality Assurance Manager - Bay City, TX* Entity/Department: Tenaris Bay City Inc.Location: Bay City, TX MAIN RESPONSIBILITES: Coordinates Quality Assurance activities, e.g. development of local documents, management of Quality events (customer claims/dissatisfaction, non-conformities, improvement actions). Develops and...
-
Manager Assurance
6 hours ago
Oklahoma City, United States HoganTaylor LLP Full timeJob DescriptionJob DescriptionJob Summary: Manage assurance engagements through all phases of the audit process with limited supervision in various industries including nonprofit, manufacturing, oil and gas, professional services, health care, governmental, wholesale/distribution, and financial institution companies, taking a leadership role with audit...
-
Quality Assurance Tech
3 weeks ago
Oklahoma City, Oklahoma, United States OK Foods, Inc Full timeThis job was posted by : For more information,please see: Job Title: Quality Assurance TechShift: 2nd ShiftScheduled Hours: Varies within the hours of (1:30pm to 2:00am)Pay Rate: *\$18.75 (*Includes \$1 Shift Differential & \$1Attendance Incentive)Bachoco OK Foods offers competitive wages and benefits to include butnot limited to:\$1/hour weekly attendance...
-
Kansas City, United States Chick-fil-A Supply LLC Full timeOverview:As the Safety, Quality & Compliance (“SQC”) Sr. Find out exactly what skills, experience, and qualifications you will need to succeed in this role before applying below. Specialist, you will lead the application of regulatorycompliance in multiple areas, including food safety quality assurance (“FSQA”) and environmental, health andsafety...
-
Quality Manager
6 hours ago
Oklahoma City, United States Mott MacDonald Full timeMott MacDonald is seeking a Quality Manager to join a large rail program in Boston, MA. This would be a leadership role on the PMCM team supporting the delivery of a diverse portfolio of projects that represent a capital investment of over $5B, strategically aligned to modernize the oldest subway in America. Projects are in various stages including planning,...
-
Quality Assurance Supervisor-off shift
1 month ago
Oklahoma City, United States Guida's Full timeQuality Assurance Supervisor-off shift #24901 Company Dairy Farmers of America Area of Interest Quality and Food Safety Job Title Quality Assurance Supervisor-off shift Description A t Dairy Farmers of America (DFA) we are proud to be a farmer-owned milk marketing cooperative. Our Beverage and Dairy Foods Division finds innovative ways to use milk...
