Quality Auditor Salary at Gracenote Inc BETA

Responsibilities: Excellent understanding of Quality Management Systems (QMS) and regulatory requirements in the medical device industry. Strong problem-solving skills with a focus on root cause analysis, CAPA, and continuous improvement. Ability to work collaboratively with cross-functional teams and communicate effectively at all levels of the organization. Proficient in the use of quality tools such as Six Sigma, PFMEA, and statistical process control (SPC). Requirements: Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or similar certifications. Minimum of 4-6 years of experience in quality assurance within the medical device manufacturing industry. Strong knowledge of validation protocol and other relevant medical device standards. Experience with process validation, risk management, CAPA, RFA, and validation protocols in a manufacturing environment.

Knowledge of Automotive Industry-specific standard IATF 16949 is a MUST. Job Responsibilities Implementation and Maintenance of QMS: They are responsible for implementing, maintaining, and improving the Quality Management System in accordance with standards like ISO 9001 or industry-specific standards such as IATF 16949, which are common in the automotive industry and ISO 14001. Transition QMS to company’s integrated management system. Maintain QMS document/record control process. Monitor QMS effectiveness through timely reporting of internal external quality metrics/objectives. Documentation Control: They ensure all process documentation, quality manuals, and quality procedures are up to date and comply with required standards. This includes developing and managing control documents and records essential for quality assurance. Audit Coordination: QMS Representatives plan and coordinate internal and external audits to check compliance with quality standards. They address any findings o

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youll also have access to: + Career development with an international company where you can grow the career you dream of. + Free medical coverage for employees* via the Health Investment Plan (HIP) PPO + An excellent retirement savings plan with high employer contribution + Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-a

**At Bayer were visionaries, driven to solve the worlds toughest challenges and striving for a world where 'Health for all Hunger for none is no longer a dream, but a real possibility. Were doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining impossible. There are so many reasons to join us. If youre hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, theres only one choice.** **Production Specialist II Cell Therapy Drug Product** **Production Specialist II - Cell Therapy Cell Culture- Berkeley, CA** **PURPOSE** This Production Specialist III is responsible for clinical manufacturing novel cell therapy drug substance within the Cell Therapy Module, CT-MOD. Collaborates closely with biological development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensur

This is an exciting opportunity to lead and manage digital quality and data integrity compliance within a cutting-edge biologics manufacturing facility. You will be responsible for overseeing 2 functional teams for Digital QA and Document Management QA up to 30 team members. This is a once-in-a-lifetime Global Expat leadership opportunity within the World’s Largest biologics CMO expanding to 720 KL total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and ADC manufacturing capabilities. Your roles and responsibility will include: Provide Oversight of the newly established Data Compliance group overseeing data integrity compliance efforts consistent with GMP and site Quality policies. Overseeing the DI framework and constituent policies, procedures, tools, and checklists governing DI and Computerized System Validation (CSV) that effectively establish data risk management stewardship and accountability throughout data and system life cycle

This is an exciting opportunity to lead and manage digital quality and data integrity compliance within a cutting-edge biologics manufacturing facility. You will be responsible for overseeing 2 functional teams for Digital QA and Document Management QA up to 30 team members. This is a once-in-a-lifetime Global Expat leadership opportunity within the World’s Largest biologics CMO expanding to 720 KL total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and ADC manufacturing capabilities. Your roles and responsibility will include: Provide Oversight of the newly established Data Compliance group overseeing data integrity compliance efforts consistent with GMP and site Quality policies. Overseeing the DI framework and constituent policies, procedures, tools, and checklists governing DI and Computerized System Validation (CSV) that effectively establish data risk management stewardship and accountability throughout data and system life cycle

This is an exciting opportunity to lead and manage digital quality and data integrity compliance within a cutting-edge biologics manufacturing facility. You will be responsible for overseeing 2 functional teams for Digital QA and Document Management QA up to 30 team members. This is a once-in-a-lifetime Global Expat leadership opportunity within the World’s Largest biologics CMO expanding to 720 KL total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and ADC manufacturing capabilities. Your roles and responsibility will include: Provide Oversight of the newly established Data Compliance group overseeing data integrity compliance efforts consistent with GMP and site Quality policies. Overseeing the DI framework and constituent policies, procedures, tools, and checklists governing DI and Computerized System Validation (CSV) that effectively establish data risk management stewardship and accountability throughout data and system life cycle

Regulatory & Quality Leadership Opportunity - Drive Innovation in Biopharma! Are you a seasoned Quality and Regulatory professional ready to take on a pivotal leadership role within a dynamic and growing biopharmaceutical organization? Our client, a cutting-edge company focused on advancing groundbreaking therapies, is seeking a highly skilled and experienced Director/Senior Director of Quality and Regulatory Affairs to join their team. What You'll Do: Strategic Quality Oversight: Spearhead supplier selection and audits, lead internal, client, and regulatory audits, and drive Quality Management and Review Board meetings. Risk Mitigation & Collaboration: Collaborate with cross-functional teams to identify and mitigate potential quality and regulatory risks, ensuring seamless operations. Regulatory Submissions & Compliance: Plan, prepare, and manage regulatory submissions (INDs, NDA/BLAs) in partnership with client stakeholders. Maintain regulatory registrations and licenses, ensuring co