The Cardiovascular &
Specialty Solutions (CSS) Group, part of the Medical Devices sector within
Johnson & Johnson, is recruiting for a Change Control Quality Engineer
located in Irvine, CA.
The CSS Group consists of six diverse
businesses including Acclarent, Advanced Sterilization Products (ASP), Biosense
Webster (BWI), Codman Neuro, Mentor, and Sterilmed. The CSS Group serves a
diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention,
Electrophysiology (EP), Neurovascular and Neurosurgery, Surgical and
Non-Surgical Aesthetics, and Reprocessing.
Advanced Sterilization Products (ASP),
division of Ethicon, Inc., a Johnson & Johnson company, truly makes a
difference by Protecting Lives against Infection. ASP has been
innovating since 1987 to help healthcare facilities protect patients with
best-in-class infection prevention solutions. Learn more about Advanced
Sterilization Products at www.aspjj.com/us
The Change Control Quality Engineer is
responsible for providing engineering support to the Change Process at ASP and
facilitating change orders through the process by effectively guiding Change
Order Owners to complete a thorough change and adequate documentation.
support for CAPAs and Non-Conformances as needed.
Change Orders (CO) through process; ensures data integrity of each CO to assure
clarity and completeness.
change classification; Analyzes and evaluates supporting documentation to
ensure that each change is effective.
monthly CO metrics.
weekly Change Control Board meetings and prepares the agenda.
weekly CCB meetings and confirm team consensus, resolve outstanding
internal and external audits as needed.
change orders (COs), document requests, and assign document numbers as
Quality System documentation.
and revises documentation to improve change control document systems and
revises procedures as needed.
guidance and support to other functional areas with documentation needs and
CO training and supports records management as needed.
independent discretion and judgment, and solves intermediate complex problems.
latitude to change work processes and workflow is provided.
administrative duties requiring limited autonomy in making decisions
independent of the current supervisor or that of the department.
of all departmental objectives and working knowledge of company operations and
organization is required.
organizational structure knowledge is required
- Bachelor Degree is required. Bachelor’s Degree in
Engineering Science or related technical field is highly preferred.
- 2-3 years in Pharmaceutical and/or Medical Device
Company is required.
- Knowledge of GDP, QSR, and ISO standards
- Good attention to detail, organizational skills and
interpersonal and communication skills are required.
- Excellent time management and problem solving skills
- Proficient in Microsoft Office applications, Adobe
Acrobat, and some knowledge of database application are required.
- Knowledge of document and data control software
- Knowledge of FDA and ISO13485 requirements are
- Knowledge/understanding of rules of part number
interchangeability, effectivity statements, configuration management,
multi-database BOM structure and interactions, and product processes as they
relate to manufacturing sites, system hierarchy and control/traceability
- Prior exposure to various functions of corporate
organization is desired.
- A Configuration Management Certification is
- Must demonstrate solid documentation experience of
document change control process.
- Good written communication skills to be able to
articulate clear and concise policies and easily understood procedures.
- Previous experience with configuration management of
product data and process instruction is preferred.
- Experience in working in change control and/or
configuration management systems is preferred.
- Experience in working with product development
and/or manufacturing is preferred.
- Experience working with global suppliers and
partners is preferred.
- This position is located in Irvine, CA. and may
require up to 10% travel.
Be VITAL in your career. Be seen for the
TALENT you bring to your work. Explore opportunities within the Johnson &
Johnson Family of Companies.
Johnson & Johnson Companies are equal
Advanced Sterilization Products (ASP)Job Function