Website Johnson & Johnson
Johnson & Johnson currently has a vacancy for those looking to work as a Johnson & Johnson Careers – Staff Quality Systems Compliance Engineer for Full Time at their offices in Redwood City, CA, US. Applicants should be sure to read the job outline attentively if they intend to apply.
|Job Title:||Johnson & Johnson Careers – Staff Quality Systems Compliance Engineer||Company Name:||Johnson & Johnson||Job Location:||Redwood City, CA, US||Job Type:||Full Time||Job Category:||Johnson & Johnson||Job Link Expiry:||2023-12-30||Posted on:||Jobinton.com|
Through Ethicon’s surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity worldwide, we deliver innovation to make a life-changing impact.
- Monitor regulatory agencies for changes in requirements and evaluates impact to the organization.
- Support Quality integration activities to support the J&J culture and credo! Assist with remediation plans that are vital to achieve these goals.
- Develop and maintain key quality and compliance performance metrics.
- Support departmental objectives, while adhering to the Johnson and Johnson Credo, as well as safety and environmental policy and procedures.
- Assists project teams with identification of quality system requirements to ensure compliance.
- Assist in the preparation and presentation of regulatory compliance training materials for regulatory, quality, technical, and managerial personnel.
- Support activities may include actively and directly interacting with inspectors/auditors, acquiring required information, and
- Partner with stakeholders and business partners to assess risk and establish proactive risk mitigation strategies and enable innovation in emerging areas.
- Collaborate with management, manufacturing, R&D, marketing company and laboratory staff to help formulate and implement proactive regulatory compliance strategies and controls.
- Participate in developing and presenting departmental materials for Management Review and Annual Product Reviews.
- Take an active role in Inspection Readiness
- Review and monitor corrective & preventative actions (CAPA); conduct follow-up activities on action items in a collaborative and efficient manner.
- Provide support for FDA, Health Authority and Notified Body inspections conducted at RAD sites, including readiness activities, front- and back-room participation/management and general inspection support as requested.
- Ability to travel up to 10%
- Experience reviewing & monitor required corrective & preventative actions (CAPA); conduct follow-up activities on required action items.
- Medical Device experience & knowledge of 21 CFR 820 & ISO 13485
- Strong communication, organizational and problem-solving skills; ability to influence.
- Project Management skills – to lead & drive the CAPA process
- Minimum of 6 years of working experience in a quality assurance & compliance environment
- Ability to present issues, plans and objectives
- Excellent problem-solving, and analytical skills
- Versatility, flexibility, and a willingness to work within evolving priorities
- Bachelor’s Degree in Engineering or related field
- Ability to work at the Redwood City, CA site
Company: Johnson & Johnson
Vacancy Type: Full Time
Job Location: Redwood City, CA, US
Application Deadline: N/A