Summary:
Plays a crucial role in ensuring that all medical devices manufactured meet the highest standards of quality and compliance. This position is responsible for overseeing the inspection processes, conducting detailed inspections, mentoring junior inspectors, and collaborating with cross-functional teams to drive continuous improvement in quality standards.
Key Responsibilities:
- Perform detailed inspections of incoming materials, in-process components, and finished products to ensure they meet established specifications and standards.
- Proficiency in using inspection tools and equipment, including calipers, micrometers, CMM, and other measurement devices. Strong understanding of GD&T, blueprint reading, and statistical process control.
- Maintain accurate and detailed records of inspection results, including non-conformances and corrective actions. Ensure all documentation complies with regulatory requirements.
- Ensure all inspection processes comply with applicable regulations and other relevant standards.
- Identify opportunities for process improvements and participate in quality improvement initiatives. Collaborate with engineering and production teams to implement corrective and preventive actions.
- Provide guidance and training to junior quality inspectors. Share best practices and ensure consistent application of quality standards.
- Assist in internal and external audits, including preparation, participation, and follow-up on audit findings.
- Ensure inspection tools and equipment are properly maintained and calibrated. Report any equipment issues or malfunctions.
- Communicate effectively with cross-functional teams, including production, engineering, and management, to resolve quality issues and support continuous improvement efforts.
- Investigate and resolve quality-related issues, including root cause analysis and implementation of corrective actions.
Qualifications:
- High school diploma or equivalent experience required. Associate's or Bachelor's degree in a related field preferred.
- Typically 7+ years of experience in quality inspection, preferably in the medical device manufacturing industry.
- Strong problem-solving skills with the ability to perform root cause analysis and implement corrective actions.
- High level of attention to detail with a commitment to maintaining the highest quality standards.
Additional Notes:
ARCH Medical Solutions is an Equal Opportunity Employer and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of Arch Medical Solutions are employed on an at-will basis.
This job description in no way states or implies that these are the only duties to be performed by the employee incumbent in this position. Employees will be required to follow any other job-related instruction and to perform any other job-related duties requested by any person authorized to give instructions or assignments.A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skill, or abilities.
