- Cepheid (Miami, FL)
- …to identify and implement improvements. This position will work with the Senior Manager Quality Systems Compliance.This position is part of the Quality ... about the Danaher Business System which makes everything possible.The Senior Quality Systems Specialist is responsible for functioning as Lead Internal Auditor… more
- Aldevron (Miami, FL)
- …solutions that safeguard and improve human health.This position is part of the Quality and Regulatory Affairs Department located in Fargo, North Dakota and will be ... a part of the Analytical Method Validation Team and report to the Sr. Manager of Analytical Method Validation. You will assist in representing the Analytical Method… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …solutions and services in more than 110 countries and regions. **Job Overview:** The Quality Manager will provide support to the Technical Director to ensure ... of Grifols USA. Generates records to comply with regulatory requirements, (cGMP QSR/ FDA /EN ISO Quality standards, Good Distribution Practices and Internal … more
- Amneal Pharmaceuticals (Brookhaven, NY)
- …, Regulatory Compliance, supports with establishing new, revising and maintaining Global Quality Standards current. The Manager , Regulatory Compliance, has a ... Description: The Manager , Regulatory Compliance, assembles a team for site-wise...direct interface with Site Quality Heads and Functional Heads with respect to FAR… more
- Barilla (Ames, IA)
- …passion. Are you ready to add your unique flavor to our journey? We are seeking a Quality and Technology Manager to join our dynamic team. In this role, you will ... Facility contact person for audit/inspection in the area of quality and food safety (eg FDA , FSSC...Organic, customers, etc). + Define budget and capex for Quality & Technology in agreement with plant manager… more
- Katecho (Des Moines, IA)
- Surmasis Pharmaceutical - Quality Manager (M - F) | Pay Based on Experience + + Job Tracking ID: 512885-892472 + Job Location: DES MOINES, IA + Job Level: Mid ... SUMMARY We are seeking a highly motivated and experienced Quality Manager to lead our quality...ensuring alignment with both internal and external standards, including FDA , EMA, ICH, and GMP. + Regulatory Compliance: Ensure… more
- Katmai (Brilliant, OH)
- **SUMMARY** Responsible for the implementation, monitoring and maintenance of the Quality System in accordance with FDA Medical Device and Drug regulations. ... FDA requirements. + Conduct and participate directly in quality inspections, internal and external audits, and FDA... quality inspections, internal and external audits, and FDA inspections. + Participate in CAPA systems. Prepare reports… more
- Insight Global (Easthampton, MA)
- Job Description Insight Global is seeking an experienced Quality Manager for our client, a key partner in the pharmaceutical sector, based in Easthampton, MA. ... This Quality Manager will oversee the QA and...FDA regulated, their customers are. Day-to-day responsibilities include: QUALITY RESPONSIBILITIES: . Responsible for being reviewer and signatory… more
- Hologic (Marlborough, MA)
- Manager , Quality Engineering Marlborough, MA, United States **Why Hologic?** Hologic empowers people to live healthier lives everywhere, every day. We are the ... the world diagnose and treat their patients with precision, certainty and confidence. The Manager of Quality Engineering will lead quality strategies to… more
- Fujifilm (College Station, TX)
- …management principles. + Strong analytical and problem-solving skills. + Certifications: Certified Quality Manager (CQM), Certified Quality Engineer (CQE) or ... data privacy regulations in the US and Europe, including GDPR. + Expertise in FDA , cGMP, ISO 13485 + Experience with Quality Systems(Deviation, OOS, CAPA, Change… more
- Cambrex High Point (Longmont, CO)
- …ensure that all activities are in compliance with company SOPs, cGMP/cGLP standards and FDA /EU regulations. The Manager of Quality Assurance leads and ... where You Matter by applying today! Job Overview The Manager of Quality Assurance is responsible for...and maintenance of procedures and policies to comply with FDA , EU, and ICH requirements applicable to site's needs.… more
- Compass Group, North America (Richmond, VA)
- ESFM Position Title: QUALITY ASSURANCE MANAGER Reports To: Salary: $75,000 - $90,000 Pay Grade: 15 Other Forms of Compensation: none ESFM is the corporate ... the Compass Employee Referral Policy, email MyReferral@compass-usa.com. Job Summary The Quality Assurance Manager is responsible for development and maintenance… more
- Element Materials Technology (Boulder County, CO)
- **Overview** Element Boulder has an exciting opportunity for a **Business Development Manager ** focused on driving sales and business growth within the medical ... on pulse oximetry, blood pressure monitoring, respiratory health technology, and FDA -regulated medical devices. + **Sales Expansion:** Drive profitable sales growth… more
- Novo Nordisk (Plainsboro, NJ)
- …projects and roles. Essential Functions + Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain ... interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Actalent (St. Louis, MO)
- Job Title: Quality Systems ManagerJob Description The Quality Systems Manager is pivotal in the design, implementation, and maintenance of food safety and ... Responsibilities + Design, implement, and maintain food safety and quality systems. + Ensure compliance with FDA ,...and quality systems. + Ensure compliance with FDA , USDA, and other regulatory bodies. + Manage internal… more
- Stryker (San Jose, CA)
- Stryker is hiring a ** Manager , Quality ** **Manufacturing** in **San Jose, CA!** As a leader for the Service business, you will lead a team of engineers ... Lead service audits (internal and external, including Corporate and ISO/ FDA ) and monitor key quality metrics to drive continuous improvements. + Ensure the team… more
- DuPont (Hemlock, MI)
- …(US 21 CFR 820) and FDA regulations. + Lead the overall Liveo (TM) Quality unit, especially with people leadership and mentoring of the Quality Team. + Work ... with relevant quality standards & regulations (eg: ISO-9001:2015, ISO-13485:2016, cGMP, FDA , etc.) as well as developing necessary controls to achieve / maintain… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …the organization's compliance posture by integrating external regulatory insights with internal quality and audit data. This position serves as the strategic bridge ... **Job Duties** + Continuously monitor and analyze global regulatory landscapes (eg, FDA , EMEA, MHRA, MDSAP, etc.) for emerging issues, guidance updates, enforcement… more
- Compass Group, North America (Middletown, PA)
- …we invite you to start your journey with us today! Job Summary The Food Quality Assurance Manager is responsible for development and maintenance of all QA ... programs, meeting USDA, FDA and customer requirements and ensuring the quality and safety of supplied goods. Must have strong knowledge in Preventive Controls… more
- Terumo Medical Corporation (Campbell, CA)
- Sr. Manager , Quality Kalila Date: May 19, 2025 Req ID: 4433 Location: Campbell, CA, US Company: Kalila Medical Inc. Department: Kalila QMRA **Job Summary** ... Senior Manager , Quality has primary responsibility for establishing...of Kalila Medical's (KMI) processes and procedures to the FDA (US) and PMDA(Japan) Quality System Regulations,… more
