Ensure compliance with GMP standards, FDA regulations, and international quality requirements while supporting manufacturing operations across multiple product lines.
The Quality Control Manager is responsible for leading and executing quality assurance strategies that align with organizational goals and continuous improvement initiatives, driving AQL-based quality standards and ensuring compliance with ISO requirements.
Responsibilities
Set clear expectations, priorities and direction for the Quality Control team aligned with company objectives
Foster a high-performance culture centered on accountability, ownership and continuous improvement
Drive AQL-based quality initiatives and ensure adherence to ISO standards and internal quality systems
Establish and maintain standardized processes for inspections and reporting to ensure consistency and accuracy
Develop, monitor, and analyze key quality KPIs on a daily basis to identify trends, risks and areas of vulnerability
Requirements
Bachelor’s of Science degree in Manufacturing, Engineering, or related field
Quality Engineer providing quality expertise and support across manufacturing operations to ensure compliance with quality standards, product specifications, and regulatory requirements.
Responsibilities
Ensure compliance with PMI, legal, environmental, health, safety, and sustainability requirements while promoting a strong safety culture
Lead and coordinate change management activities to maintain validated manufacturing processes, systems, and methods
Conduct risk assessments and track quality metrics
Manage material quality programs, including incoming material inspections, acceptance criteria, non-conformance handling, root cause investigations, and corrective actions
Support and maintain the Quality Management System (QMS), ensuring compliance with internal standards, Good Manufacturing Practices (GMP), and ISO requirements
Requirements
Bachelor’s degree in engineering, Biological Sciences, Physical Sciences, or a related field
Lead or contribute to the mechanical design of optical assemblies, mounts, and structures for imaging and sensing systems.
Perform Structural, Thermal, and Optical Performance (STOP) analysis and Structurally Induced Line of Sight (SILOS) analysis to ensure system performance over expected environmental and operational conditions.
Develop complex 3D CAD models, detailed part/assembly drawings, and associated documentation.
Work collaboratively with optical, systems, electrical, and manufacturing engineering teams to refine requirements and ensure design feasibility and producibility.
Support environmental test planning, execution, and correlation of analysis with test results (vibration, thermal, shock, etc.).
Requirements
Bachelor’s degree in Mechanical Engineering, Optical Engineering, Physics, or related discipline
Master’s degree in Mechanical Engineering, Optical Engineering, Physics, or related discipline
PhD in Mechanical Engineering, Optical Engineering, Physics, or related discipline
Contribute to the mechanical design of optical assemblies, mounts, and structures for imaging and sensing systems.
Perform Structural, Thermal, and Optical Performance (STOP) analysis and Structurally Induced Line of Sight (SILOS) analysis to ensure system performance over expected environmental and operational conditions.
Develop parametric 3D CAD models, detailed part/assembly drawings, and associated documentation.
Collaborate with optical, systems, electrical, and manufacturing engineering teams to refine requirements and ensure design feasibility and producibility.
Support environmental test planning, execution, and correlation of analysis with test results (vibration, thermal, shock, etc.).
Requirements
Bachelor’s degree in Mechanical Engineering, Optical Engineering, Physics, or related discipline
Master’s degree in Mechanical Engineering, Optical Engineering, Physics, or related discipline
PhD in Mechanical Engineering, Optical Engineering, Physics, or related discipline
Nice to have: MS/PhD in Optical Engineering, Mechanical Engineering, Physics
Nice to have: hands-on experience with STOP and SILOS modeling workflows
Lead first shift manufacturing operations of a CNC machining company of medical devices, ensuring production, safety, quality, and regulatory compliance.
Compensation
$71,000.00 - $98,000.00 USD Salary
Responsibilities
Lead day-to-day execution of manufacturing and assembly
Ensure production maintained per safety, schedules, engineering specs, quality standards, FDA, ISO, GMP
Manage performance and development of direct reports
Administer company policies and procedures in Manufacturing Department
Ensure compliance with GMP, ISO, safety policies
Requirements
High School diploma or equivalent required
Associate degree or higher preferred from a technical institute, Journeyman, or other technical training and certifications
Nice to have: Associate degree or higher
Nice to have: Technical training and certifications
