Quality Engineer
Michael Page
- Brand New Position Reporting into Global Director of Quality!
- Growing Clinical Skincare Brand! Hybrid Role in NYC!
About Our Client
Join a growing, global clinical skincare brand!
Job Description
* Develop, implement, and maintain quality assurance processes and procedures in alignment with industry standards and regulations.
* Ensure all manufacturing processes comply with relevant regulations, including but not limited to FDA, EMA, ICH, and GMP guidelines.
* Review batch records, validation documentation, and quality control data to ensure compliance and product quality as needed.
* Review and trend costumer complaints and ensure issuance and closure of nonconformance reports when applicable.
* Prepare detailed CAPA (Corrective and Preventive Actions) reports, and other documentation as required.
* Maintain thorough and accurate records of quality assurance activities, audits, and regulatory communications.
* Participate in the preparation and review of SOPs, work instructions, and other quality-related documents.
* Lead or participate in continuous improvement initiatives, focusing on quality and operational efficiency.
* Assist suppliers in understanding and implementing Client product specifications.
* Support line trials and startups and contract manufacturers as needed.
The Successful Applicant
* Bachelor's degree in engineering or related technical field.
* Minimum of 3-4 years of experience in quality assurance within the cosmetic industry.
* Experience with regulatory bodies such as the FDA, EMA, and other international regulatory agencies.
* Familiarity with Quality Management Systems (QMS), CAPA, deviation management, and risk management.
* Strong understanding of GMP regulations, FDA guidelines, and other applicable industry standards.
* Excellent analytical and problem-solving skills.
* Exceptional attention to detail and ability to identify potential areas of risk and non-compliance.
* Strong verbal and written communication skills, with the ability to prepare clear and concise reports.
* Ability to travel domestically and internationally up to 25% of the time.
What's on Offer
- Competitive salary ranging from $90,000 to $105,000 annually, depending on experience.
- Comprehensive benefits package.
- Opportunities for professional growth and development.
- Collaborative and supportive work environment with exposure to C-Suite
- HYBRID working structure - 3 days/week on-site in Midtown Manhattan & 2 days/week remote
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