Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse, Will work with hazardous/toxic materials

Job Description

Position Overview: We are seeking a highly organized and detail focused Manufacturing Quality Control (MQC) and Incoming Quality Assurance (IQA) Supervisor to join our team at our ISO 13485 certified facility. As the Supervisor, you will be responsible for overseeing the quality control activities within our manufacturing and incoming material processes, to ensure alignment with ISO 13485 standards and regulatory guidelines. Your primary focus will be to maintain and improving product quality, monitor process performance, and drive initiatives for continuous improvement.

Key Responsibilities:

Oversee and manage the daily operations of the Manufacturing Quality Control (MQC) and Incoming Quality Assurance (IQA) departments, ensuring adherence to ISO 13485 standards and regulatory requirements.Develop and implement quality control procedures and protocols to monitor and ensure the consistency and reliability of quality for manufacturing processes and products.Conduct inspections of in process raw materials, components, and finished goods to verify compliance with specifications and quality standards.Collaborate with cross-functional teams, including Manufacturing, Engineering, and Quality Assurance, to identify and address quality issues.Monitor and analyze quality metrics, to identify trends and areas for improvement.Provide guidance and support to manufacturing personnel on quality-related matters, including training on quality control procedures and standard processes.Maintain knowledge of current industry trends, regulatory updates, and best practices in manufacturing quality, cGMPs, etc. Implement any necessary changes to remain compliant with standard requirements.

Demonstrates and drives the Thermo Fisher values – Integrity, Intensity, Involvement, and Innovation (The Four Is).

Education:

Minimum requirements candidates must have accreditations or associate degree.Equivalent combinations of education, training, and significant work experience.Individuals with certifications in Quality Control or Quality Assurance are also desirable.

Preferred Qualifications and Skills:

Minimum of 7 years of experience in a quality control or quality assurance role within a manufacturing environment.Strong knowledge of ISO 13485 requirementsProficiency in quality control methodologies and tools, such as statistical process control, sampling plans, and inspection techniques.Experience with conducting root cause analysis and implementing corrective and preventive actions.Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate quality-related information to non-technical team members.Strong investigative and problem-solving abilities, with a thorough attention to detail.

Knowledge, Skills, Abilities:

Knowledge of cGMPsOutstanding problem-solving skillsAttention to detailAbility to multi-taskExcellent oral and written communications skillsAbility to work with company/client confidential informationCommunicate effectively with all levels of personnelWork efficiently and accurately in a fast-paced environment

We offer a competitive salary package, a supportive work environment, and opportunities for professional growth and development for highly motivated individual with a passion for maintaining product quality and driving continuous improvement.