Staff Quality Assurance Specialist
hace 4 semanas
At Johnson & Johnson, we are committed to pioneering and innovation, impacting the health of over 1 billion patients and consumers every day. Our diversity, equity, and inclusion initiatives are essential to our success.
We are seeking a talented Staff Quality Engineer to join our team in Juarez, Chihuahua, at our Plant Salvarcar. This role will be responsible for quality engineer activities for existing and new medical device technologies developed at Coherex Medical.
Purpose:
Manage projects as assigned, interfacing with R&D and Manufacturing engineers and other staff members. Perform quality engineering tasks such as development of PQ validation protocols, execution, and report writing.
Responsibilities:
Under general direction, this position will:
- Perform quality systems support in areas of inspection, MRB, calibration, CAPAs, PMs, internal auditing, supplier qualification & auditing, customer complaints, and post-market surveillance.
- Work with R&D and Manufacturing engineers to identify opportunities for improvement and validation of processes.
- Ensure conformance of product to specifications and requirements are met.
- Develop and maintain documentation that defines the company's quality engineering procedures.
- Participate in company validation programs for existing and new manufacturing processes.
- Apply process controls and assess data acquired from process measurement systems.
- Identify tools and methods required to ensure product compliance to specifications and process robustness.
- Manage quality engineering activities for the company.
- Interface with other departments to integrate quality engineering activities with company objectives and priorities.
- Ensure regulatory requirements are met during quality engineering activities.
- Perform other related duties and tasks as needed.
Qualifications:
Required qualifications include:
- Bachelor of Science in Engineering, preferably Mechanical or Manufacturing engineering.
- Strong knowledge of the medical device industry and quality and regulatory systems, including FDA's Quality System Regulation and ISO 13485.
- Excellent written and verbal communication skills.
- Ability to read, write, and verbally communicate effectively in English.
- A minimum of five years of quality engineering or closely related experience in the medical device industry.
- Experience with project planning and management tools.
- Demonstrated experience managing projects requiring multi-disciplinary inputs.
- Ability to handle multiple priorities/projects in an effective manner.
- Strong interpersonal skills and the ability to communicate effectively with others.
- Excellent organizational skills.
- Strong technical writing skills.
- Knowledge and practice of statistics for validation.
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