Our partner is seeking a Quality Assurance Specialist to join our Operations team. This role requires a passion for exceeding consumer quality expectations and a commitment to strengthening and continuously improving our global Quality Management System (QMS). The position supports products across multiple categories, including medical devices, cosmetics, and OTC drugs.

Responsibilities to include:

• Maintain QMS procedures, forms, records, and training; ensure controlled documents are current and effective.
• Manage filing, access, retrieval, and retention periods for records and documents.
• Review Quality System Records for conformance and compliance.
• Author, review, and approve SOPs, work instructions, forms, and controlled logbooks.
• Execute product release activities, verify required documentation, manage holds and dispositions, and escalate deviations as needed.
• Establish and improve product and process quality through individual and team-based problem-solving using industry best practices.
• Prepare for and participate in internal and external audits and inspections; track findings to closure.
• Identify opportunities for improvement, recommend solutions, and drive implementation.
• Collaborate with Engineering and Quality departments during product development to ensure compliance throughout design and manufacturing processes.
• Review Engineering Change Orders related to design, engineering, or manufacturing.
• Partner with internal auditors and quality managers on compliance-related matters.
• Provide support on development projects and regulatory issues to ensure timely submissions for market clearance.
• Collaborate cross-functionally to drive continuous improvement in yield, defect reduction, and customer experience.

What You Will Need

• Bachelor’s degree in engineering, Science, or another technical field.
• 2+ years of relevant experience, ideally within the medical device, cosmetics, or other regulated industries
• Familiarity and experience with regulatory requirements (ISO 9001 is required; ISO 13485 strongly preferred
• Energetic, positive team player who thrives in an entrepreneurial environment.
• Strong advocate for product excellence and quality.
• Analytical skills with the ability to make data-driven decisions and communicate effectively.
• Highly organized with the ability to manage multiple priorities and tasks with strong attention to detail.
• Ability to identify opportunities, recommend improvements, and implement solutions.
• Strong written and verbal communication skills.

Who You Will Work With

Our partner is an organization that values collaboration and community. As the Quality Assurance Specialist, you will work closely with Operations, RD&E and Project Management teams.

Posted On: Monday, September 8, 2025