Quality Control Manager (Medical Device Manufacturing)

Job Description

Job Description

Salary: $115,000 - $145,000/yr or commensurate with experience

LifeLens Technologies, Inc. is a medical device developer located in Ivyland, PA. We are pioneering innovative, next generation, treatment devices for personal health monitoring.

Quality Control Manager (Medical Device Manufacturing)

Type: Full-time, on-site
Experience Level: 7+ years

About the Role

The Quality Control Manager plays a critical role in assuring the quality of LifeLens products, the maintenance of its manufacturing related quality systems, and compliance with Medical Device Quality System Regulation and ISO 13485. In this role, you will be responsible for developing and deploying the QC program by integrating testing and inspection processes into product, component and raw material Quality Control Plans, monitoring and measuring effectiveness and implementing improvements.

To be successful in this role, the candidate must have a strong quality and process engineering background, prior supervisory experience in a production environment and experience in implementing quality control processes in a manufacturing environment.

The ideal candidate is a detailed oriented problem solver capable of implementing effective solutions. You will have the opportunity to work on state-of-the-art equipment. Your passion and drive will be rewarded with a competitive salary, benefits, and long-term growth opportunities.

This position reports to the V.P. of Quality and Project Management.

Responsibilities

• Lead, manage, and develop/coach Quality Control staff to monitor and continually improve personnel performance and product quality inspection methods and effectiveness.
  
• Proactively drive the implementation and evaluation, monitoring, and continuous improvement of quality control inspection methods and efficiency opportunities.
• Review and coordinate intradepartmental approval of internal and externally generated NCRs, CAPAs, Deviations, and other Quality System inputs using established procedures and work instructions.
• Ensure the nonconforming material identified from receiving, in-process, and finished device acceptance is identified, documented, and communicated to affected parties for timely and effective resolution
• Ensure quality control inspection plans, tests and methods are adequately developed (including test/inspection equipment), implemented, maintained and utilize statistical methodology, where appropriate, for receiving, in-process, and finished device acceptance.
• Strong communication, collaboration, and teamwork with other departments to ensure the effective execution of the quality system

Supervisory Responsibilities

• Accomplish department objectives by supervising staff and organizing and monitoring work processes.
• Maintain staff by recruiting, selecting, orienting, and training employees and developing personal growth opportunities.
• Accomplish staff job results by coaching, counseling, and disciplining employees.
• Administer performance reviews
• Conduct training
• Implement and enforces Company systems, policies, and procedures.
• Maintain safe and healthy work environment by establishing and enforcing Company standards and adhering to legal regulations.

Qualifications

• Bachelors Degree required in engineering (preferably Electrical Engineering), Science, or related field
• 5 years of quality systems, quality control, and/or quality engineering experience required, including experience in implementing a QC program, preferably in medical device manufacturing
• 3 years of people leadership experience required
• Strong leadership skills and ability to collaborate effectively with team members and stakeholders.
• Experience in building a quality control program at a technologically complex manufacturing organization.
• Experience implementing quality control concepts, test methods, equipment and applicable national standards relating to testing (i.e. ASTM standards, etc.).

Work Environment

This job operates in a professional office environment and in a laboratory environment. This position requires using laboratory equipment and PPE, for which appropriate training will be provided. It also routinely uses standard office equipment (computers, etc)

Benefits

• Health, Dental & Vision Insurance
• Paid Time Off
• 401(k)