About The Position
As part of the Quality team, you will play a critical role in ensuring our products meet the highest standards of quality, safety, and compliance before they reach our customers. This is an excellent opportunity to work in a collaborative, fast-paced environment where attention to detail, continuous learning, and a commitment to excellence directly impact patient outcomes.
Requirements
- Strong attention to detail and a commitment to accuracy in documentation, inspections, and quality processes.
- Able to effectively manage multiple priorities while maintaining compliance and meeting deadlines.
- Strong organizational, communication, and problem-solving skills.
- Work well both independently and collaboratively with cross-functional teams.
- Adaptable and willing to learn new processes, systems, and responsibilities.
- Experience working within a regulated environment such as medical device, manufacturing, pharmaceutical, or a related industry.
- Quality-focused mindset and a commitment to continuous improvement.
- Proficiency with Microsoft Office applications and electronic quality systems.
- Understand the importance of Good Documentation Practices (GDP), compliance, and maintaining high-quality standards in a regulated environment.
- Typically requires a minimum of 2-4 years of related experience and a High School diploma/certificate or equivalent.
Nice To Haves
- Experience with Agile/PLM, Oracle, Camstar, or similar systems is preferred.
Responsibilities
- Perform in-process and final document reviews to ensure accuracy, completeness, proper formatting, signatures, dates, and compliance with Good Documentation Practices (GDP).
- Maintain compliance with operating procedures and complete all required training before performing assigned tasks.
- Ensure documentation is legible, complete, and accurate.
- Inspect labels and packaging to verify compliance with established quality standards.
- Review and approve manufacturing line clearance activities to support product quality and compliance.
- Conduct in-process quality audits within manufacturing to ensure adherence to manufacturing documentation and GDP requirements.
- Assist with the Nonconforming Material Report (NCMR) process for commercial and clinical products.
- Perform in-process product inspections and testing activities for commercial and clinical products.
- Develop an understanding of manufacturing processes and quality requirements to effectively support production operations.
- Provide training and guidance to new employees on quality processes and procedures.
- Proactively take on new challenges and support additional responsibilities within the Quality department as business needs evolve.
- Maintain strong organizational practices while managing multiple priorities in a fast-paced environment.
- Perform other duties and projects as assigned.
Benefits
- A full and comprehensive benefits program.
- Growth opportunities on a global scale.
- Access to career development through in-house learning programs and/or qualified tuition reimbursement.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
