Manager, Quality Salary at Nasoya BETA

Quality Manager Cytonome, LLC. – Lexington, MA Job Overview Cytonome is a subsidiary of the global STgenetics group, an international leader of livestock reproductive services. Cytonome is based in the heart of the Massachusetts technology corridor and has additional research and development (R&D) teams in Texas and New Zealand. In 2021, we expanded our software capability via acquisition of Verity Software House, the cytometry software experts. Our facilities include an ISO 8 cleanroom for GMP consumable manufacturing, biological laboratory facilities (BSL2), and extensive engineering and R&D facilities. Cytonome operates under a quality management system compliant to ISO 9001:2015 and ISO 13485:2016 We are seeking an experienced Quality Manager to add to our team. As the Quality Manager, you will be responsible for delivering safe, reliable, compliant, and quality products that meet customer expectations. Reporting to the General Manager of Operations, you will be responsible for lea

Job Description Job Description At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).  Position Summary: The Quality Operations (QAOps) Manager is responsible for the oversight of the quality compliance activities associated with the day-to-day Quality Operations which includes CMO relationships. The individual will work cross functionally to support site projects as well as clinical and commercial products. This role will be focused on Vericel’s Medical Device products. Schedule: As a company that thrives on teamwork and collaboration, this role will be required to work five days per week on-site. Position Scope: Quality Ops Responsibilities: Provide guidance and e

Job Description Job Description At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).  Position Summary: The Quality Operations (QAOps) Manager is responsible for the oversight of the quality compliance activities associated with the day-to-day Quality Operations which includes CMO relationships. The individual will work cross functionally to support site projects as well as clinical and commercial products. This role will be focused on Vericel’s Medical Device products. Schedule: As a company that thrives on teamwork and collaboration, this role will be required to work five days per week on-site. Position Scope: Quality Ops Responsibilities: Provide guidance and e

Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients. What Sarepta Offers At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resourc

Job Description: Participate in the New Product Development (NPI) and design changes, Design History File (DHF) and Device Master Record (DMR) reviews meetings and fully understand the design control process and Quality Engineering. Utilize technical training and compliance experience to ensure that company design control projects comply with internal design control procedures in accordance with FDA and ISO requirements. ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE: Responsible for overall Design Quality process to ensure that company design control projects comply with internal design control procedures in accordance with FDA, ISO and other applicable requirements. Act as a subject matter expert on design control process and risk management process. Lead Risk Management activities from Product Concept through Commercialization. Provide guidance to internal and external stakeholders and ensure that design control requirements are being met in an effective manner in order to achiev

Vendor Quality Management Manager Key Duties and Responsibilities: Monitors metrics and dashboards for emerging trends for vendors in assigned GMP/GDP area(s). Ensures adequate management and mitigation of risk arising from vendors Supports processes and procedures to report on, manage, and mitigate vendor risk to acceptable levels. Leads and/or participates in process and system improvement efforts as a vendor quality SME. Provides onsite front and/or back room inspection support as assigned Provides insight on vendor risk and its potential impact in quality and business forums Must Have: Strong knowledge of regulatory requirements in GMP/GDP areas Demonstrated experience with key performance indicators and quality metrics for vendors Expertise in risk assessment as it pertains to third parties / suppliers Strong interpersonal skills to explain difficult information and work to build alignment Demonstrated ability to communicate effectively, both orally and in writing Mathematical acu

QUALITY MANAGER Full Time (40 hours) Summary of Position Quality Manager to manage and continuously improve the quality of products and services. To monitor conformance to customer and company requirements as defined in ISO9002. To assist in improving manufacturing's production output and efficiency. Requirements 4 years of related experience in mechanical inspection Knowledge of quality control procedures, math, data analysis and statistical methods Motivated Leader and Collaborative Team Player Professional/Effective Communication (verbal, written and interpersonal) Ability to analyze and identify problems, strong attention to detail Continuous Improvement Mindset to enhance the quality of products/service and efficiency/effectiveness of the process Strong Organization and Multi-tasking skills Experience with ERP systems and Excel Responsibilities Manage CSM Quality Team: delegate daily inspections and shipments, approve work schedules/vacations, execute yearly appraisals, and provid

Vendor Quality Management Manager Key Duties and Responsibilities: Monitors metrics and dashboards for emerging trends for vendors in assigned GMP/GDP area(s). Ensures adequate management and mitigation of risk arising from vendors Supports processes and procedures to report on, manage, and mitigate vendor risk to acceptable levels. Leads and/or participates in process and system improvement efforts as a vendor quality SME. Provides onsite front and/or back room inspection support as assigned Provides insight on vendor risk and its potential impact in quality and business forums Must Have: Strong knowledge of regulatory requirements in GMP/GDP areas Demonstrated experience with key performance indicators and quality metrics for vendors Expertise in risk assessment as it pertains to third parties / suppliers Strong interpersonal skills to explain difficult information and work to build alignment Demonstrated ability to communicate effectively, both orally and in writing Mathematical acu