Quality Engineer

Mindlance; West Chester (Chester County); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical device firm is seeking a Quality Engineer in West Chester, PA. The role involves ensuring compliance with quality systems for drug injection devices while collaborating with global teams. The ideal candidate should have a BA/BS degree and 5+ years of related experience. Responsibilities include monitoring compliance with regulations and improving product quality through established procedures. This is an on-site position with potential for extension.

Qualifications

• 5+ years of experience in quality engineering or related field.
• Familiarity with drug injection device design control processes.
• Experience with quality audits and standard operating procedures.

Responsibilities

• Ensure compliance with CMO policies and quality management processes.
• Monitor and improve product quality and supplier processes.
• Communicate with device development and compliance teams internationally.

Skills

Quality System compliance

Knowledge of 21 CFR Part 820 regulations

Analytical problem-solving

Process improvement

Education

Undergraduate/BA/BS degree in applicable discipline

Job description

Duration: 6+ Months (Possible Of Extension)

Location: West Chester, PA

The Quality Engineer (QE) works on-site with the local CMO in drug injection device design control processes. The QE represents company interests in the current projects. Duties will include assuring that CMO teams follow a 21 CFR Part 820 compliant Quality System from product concept through industrialization and post market support. The individual shall be a subject matter expert (SME) in these regulations for the US and furthermore support and provide expertise to global Compliance and Device Design Control functions in this area. This position will assure that company GMP expectations of the CMO policies and quality management system processes are fulfilled. The QE will additionally have responsibility for company interest in component manufacture and product qualification activities of a primary vendor local to the Plymouth, MN site, in addition to the same responsibilities at a separate vendor with two sites in Massachusetts. The position will have reporting responsibilities and thus frequent and written contact with company device development and compliance teams in Runcorn, UK and Pennsylvania, US will be expected in a project‑based environment. Monitors CMO policies, procedures and methods to evaluate and improve the quality of products, materials, components and/or operations. Develops, assures and maintains the quality of products and processes, including standard procedures (e.g., 21 CFR Part 820), quality audits/review, method development, process reengineering, etc. Supports the total quality function of a plant or group of plants. Ensures adherence to and compliance with established company/CMO company quality policies, best practices, standard operating procedures (SOP's) and government regulations. Ensures quality of materials processed, manufactured and/or distributed by the company.

• Builds knowledge of the organization, processes and supplier processes.
• Solves a range of straightforward problems.
• Analyzes possible solutions using standard procedures.
• Receives a moderate level of guidance and direction from global management.

Undergraduate/BA/BS degree in applicable discipline and 5+ Yrs of related experience.

Qualifications

Undergraduate/BA/BS degree in applicable discipline and 5+ Yrs of related experience.

Additional Information

All your information will be kept confidential according to EEO guidelines.