Overview
Quality Engineer Jobs in Bloomington, IN at Tasus Corporation
Company: Paragon Laboratories USA.
Location: Torrance, CA.
Salary: Starts at $140,000+.
Position Summary:
The Director of Quality and Regulatory Compliance is responsible for developing, implementing, and managing quality systems and regulatory compliance strategies to ensure that products meet all required quality standards and comply with applicable federal, state and local regulations. This leader will serve as the primary liaison with regulatory agencies and will guide cross-functional teams in matters related to quality assurance, regulatory submissions, audits, and continuous improvement. If you’re committed to maintaining the highest standards of product quality, regulatory compliance, and customer technical support, we encourage you to apply.
Duties and Responsibilities:
Develop, implement, and continuously improve the Quality Management System (QMS) in alignment with cGMP, FDA, EPA, OSHA, Health Canada, and other applicable regulations.
Define and execute regulatory and quality strategies that support business growth, product innovation, and global market access.
Serve as the subject matter expert and primary contact for regulatory inspections and audits (FDA, NSF, NPA, UL, QAI, etc.).
Lead and develop the Quality, Regulatory, and QC teams with a focus on performance, compliance, and professional growth.
Champion a quality-first culture through cross-functional training, communication, and leadership.
Oversee and approve SOPs, protocols, validations, quality reports, and internal audits to ensure consistent and compliant operations.
Manage the CAPA system, change control, and deviation management processes to drive timely and effective resolution of non-conformances.
Ensure raw material and finished product specifications meet regulatory and customer expectations, in collaboration with R&D and site quality teams.
Lead Management Review process, compiling and analyzing Quality KPIs and metrics to guide decision-making and identify improvement opportunities.
Maintain up-to-date knowledge of regulatory changes and ensure company compliance with evolving requirements.
Manage regulatory submissions, product registrations, and certifications to support domestic and international product distribution.
Develop and maintain quality and regulatory agreements with customers, ensuring clarity of responsibilities and expectations.
Support new product introductions by advising on regulatory strategy, labeling, claims, and documentation.
Develop and manage departmental budgets, staffing plans, and resource allocation.
Collaborate with manufacturing, supply chain, and R&D teams to integrate quality principles into product lifecycle management.
Support Sales and customers on Quality-related matters.
Required Qualifications:
Bachelor’s degree in a scientific discipline (Chemistry, Biology, Pharmaceutical Sciences, or related). Advanced degree preferred.
10+ years related experience in Pharmaceutical/ Nutraceuticals GMP regulated manufacturing environment; with at least 3 years in a leadership capacity.
Extensive knowledge of regulatory standards including FDA 21 CFR Part 111/117/211, cGMP, Health Canada, NSF, etc.
Proven track record of successful regulatory inspections and quality system leadership.
Strong strategic thinking, communication, and organizational skills.
Proficiency in managing and mentoring cross-functional quality teams.
Certification in Quality or Regulatory Affairs (e.g., ASQ, RAC) a plus.
Benefits Include:
Competitive salary and performance-based bonuses.
Comprehensive health, dental, and vision insurance plans.
Retirement savings plan with company matching.
Opportunities for professional development and growth.
A positive and inclusive work environment that fosters collaboration and creativity.
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Title: Quality Engineer
Company: Tasus Corporation
Location: Bloomington, IN
