Advanced Instruments, LLC
Overview
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Quality Compliance Specialist
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Advanced Instruments, LLC . At Advanced Instruments, now proudly part of Nova Biomedical, we’re not just building instruments, we’re powering breakthroughs that improve lives. As a global leader in analytical technologies for the biopharmaceutical and clinical markets, our solutions are trusted in over 100 countries to accelerate drug development and enhance patient care. Our integration brings together over 70 years of scientific excellence with Nova’s cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. From FDA-registered, ISO-certified manufacturing to 125+ FDA approvals and industry-trusted diagnostics, we set the standard for quality and reliability. Advanced Instruments is also the global leader in osmolality testing, with a legacy of innovation that continues to shape the future of life sciences. We’re headquartered in Norwood and Waltham, Massachusetts, with a growing global presence and a collaborative culture grounded in our values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity. Explore what’s next with us at http://www.novabiomedical.com or https://www.aicompanies.com. What we are looking for
We are looking for a Quality Compliance Specialist who will provide support to the QA function by performing activities associated with customer product complaints, including receipt, evaluation, investigation, trending, reporting, and closure. They also provide support for other functions such as Post-market Surveillance (PMS). The Quality Compliance Specialist will take primary ownership for complaints and post-market surveillance utilizing the Sales Force platform. You will conduct preliminary complaint investigations including DHR review, shipment and lot history review, and trending to aid in determination of root cause. You will promote a culture of quality focused on compliance with customer needs and regulatory requirements. Responsibilities
Take primary ownership for customer complaints and Post-Market Surveillance (PMS) activities. Conduct preliminary complaint investigations including DHR review, shipment and lot history review, and trending to aid in root cause determination. Support QA functions related to regulatory compliance and customer needs. Promote a culture of quality and compliance within the organization. Qualifications
Bachelor’s Degree in scientific/technical discipline Quality / Regulatory certifications is a plus 5-8 years related experience and/or training; or equivalent combination of education and experience Experience with Salesforce and/or Epicor Must be able to use Microsoft Office, Adobe, and be comfortable with eQMS and ERP software Knowledge of ISO 13485, MDSAP and FDA QSR required; other regulatory jurisdictions strongly preferred Experience with in vitro diagnostics (IVD / IVDR) preferred; other relevant experience a plus Minimum 4 days onsite requirement to support the business, 1 day remote Work Location
Norwood, MA What’s in it for you?
Flexible Medical, Dental, & Vision Coverage Competitive 401k company match Bonus Program, Generous PTO and paid holidays Generous Tuition reimbursement Hybrid and flexible work arrangements Professional development, engagement and events Company marketplace for lunch and snacks EEO Statement
Advanced Instruments takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Advanced Instruments will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Privacy policy https://advancedinstruments.showpad.com/share/DmsEd5QTLlqemTYABlvDW
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Join to apply for the
Quality Compliance Specialist
role at
Advanced Instruments, LLC . At Advanced Instruments, now proudly part of Nova Biomedical, we’re not just building instruments, we’re powering breakthroughs that improve lives. As a global leader in analytical technologies for the biopharmaceutical and clinical markets, our solutions are trusted in over 100 countries to accelerate drug development and enhance patient care. Our integration brings together over 70 years of scientific excellence with Nova’s cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. From FDA-registered, ISO-certified manufacturing to 125+ FDA approvals and industry-trusted diagnostics, we set the standard for quality and reliability. Advanced Instruments is also the global leader in osmolality testing, with a legacy of innovation that continues to shape the future of life sciences. We’re headquartered in Norwood and Waltham, Massachusetts, with a growing global presence and a collaborative culture grounded in our values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity. Explore what’s next with us at http://www.novabiomedical.com or https://www.aicompanies.com. What we are looking for
We are looking for a Quality Compliance Specialist who will provide support to the QA function by performing activities associated with customer product complaints, including receipt, evaluation, investigation, trending, reporting, and closure. They also provide support for other functions such as Post-market Surveillance (PMS). The Quality Compliance Specialist will take primary ownership for complaints and post-market surveillance utilizing the Sales Force platform. You will conduct preliminary complaint investigations including DHR review, shipment and lot history review, and trending to aid in determination of root cause. You will promote a culture of quality focused on compliance with customer needs and regulatory requirements. Responsibilities
Take primary ownership for customer complaints and Post-Market Surveillance (PMS) activities. Conduct preliminary complaint investigations including DHR review, shipment and lot history review, and trending to aid in root cause determination. Support QA functions related to regulatory compliance and customer needs. Promote a culture of quality and compliance within the organization. Qualifications
Bachelor’s Degree in scientific/technical discipline Quality / Regulatory certifications is a plus 5-8 years related experience and/or training; or equivalent combination of education and experience Experience with Salesforce and/or Epicor Must be able to use Microsoft Office, Adobe, and be comfortable with eQMS and ERP software Knowledge of ISO 13485, MDSAP and FDA QSR required; other regulatory jurisdictions strongly preferred Experience with in vitro diagnostics (IVD / IVDR) preferred; other relevant experience a plus Minimum 4 days onsite requirement to support the business, 1 day remote Work Location
Norwood, MA What’s in it for you?
Flexible Medical, Dental, & Vision Coverage Competitive 401k company match Bonus Program, Generous PTO and paid holidays Generous Tuition reimbursement Hybrid and flexible work arrangements Professional development, engagement and events Company marketplace for lunch and snacks EEO Statement
Advanced Instruments takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Advanced Instruments will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Privacy policy https://advancedinstruments.showpad.com/share/DmsEd5QTLlqemTYABlvDW
#J-18808-Ljbffr