JOB TYPE: Direct Hire
LOCATION: Dakota County, MN
REMOTE / ONSITE: Onsite
POSTED: Nov 15, 2024
Our client is a certified entity, regulated by the FDA, and registered with the ATF, EPA, and the Minnesota Department of Health. Our client specializes in manufacturing personal care products, focusing on the health, beauty, and cosmetic sectors. Their product range includes specialized offerings in sun care, skin care, hair care, over-the-counter (OTC) medications, and nutritional supplements. Currently, they are looking to add a Quality Regulatory Compliance Engineer (Personal Care / Manufacturing) to their team.
Salary/Hourly Rate:
$80k – $110k Annually
Position Overview:
The objective of this role is to improve quality within production to meet our customer’s needs and expectations. The Quality Regulatory Compliance Engineer (Personal Care / Manufacturing) will focus on process and equipment improvements, develop quality control systems and processes, and attack quality system failures using effective root cause analysis methods. The Quality Regulatory Compliance Engineer (Personal Care / Manufacturing) will concentrate on continuous improvement through the implementation of effective Corrective and Preventive Actions (CAPA). The Quality Engineer (Personal Care / Manufacturing) will play a key role in ensuring that products meet industry standards, regulatory requirements, and internal quality objectives while promoting a culture of compliance and continuous improvement across the organization.
Responsibilities of the Quality Regulatory Compliance Engineer (Personal Care / Manufacturing):
- To stop recurrences, take the lead in quality-related problem-solving and root cause analysis in manufacturing.
- To guarantee product quality and regulatory compliance, take part in the technical issue investigation, testing status, and method and CAPA establishment.
- Verify that systems and products meet quality standards by conducting surveys, audits, and inspections of suppliers and construction companies.
- Work autonomously while attending important meetings as a representative of the quality organization to prepare and address important issues.
- Organize multidisciplinary groups to handle deviations, CAPAs, change controls, and out-of-specifications.
- Determine the fundamental cause of issues and assess the efficacy of solutions by identifying and analyzing quality issues in manufacturing, QC laboratories, and analytical laboratory testing.
- Collaborate with internal teams to determine and create important quality indicators, and make sure that quality data is analyzed methodically to spur changes.
- Write and update SOPs, carry out internal audits, and support the Quality Organization in raising organizational awareness of quality and providing training.
- Make sure that all company policies, procedures, and quality standards—such as safety, environmental, and Good Manufacturing Practices (cGMP)—are followed.
- Attend safety, GMP, and other training classes that the employer requires.
Qualifications for the Quality Regulatory Compliance Engineer (Personal Care / Manufacturing):
- 3 – 5 years of experience in manufacturing, cosmetics, medical device, or pharmaceuticals.
- An ASQ Certified Quality Engineer (CQE) certification is a plus.
- Strong knowledge of quality systems (ISO 9001, GMP, FDA regulations), personal care industry standards, and regulatory compliance.
Education Requirements:
- Bachelor’s degree, or 1 – 2 years with a Master’s degree is required.
Benefits:
- Health, dental, and vision.
- Short-term disability.
- Long-term disability.
- Life insurance.
- PTO.
- Sick leave.
- Parental leave.
- 401(k).
EOE/M/F/D/V/SO