ANALYST, QUALITY DOCUMENTATION

Biosense Webster is recruiting for an Analyst, Quality Documentation to be located in Santa Rosa, CA.
The Analyst, Quality Documentation is responsible for maintaining a Document Control system that meets regulatory, quality and company requirements.
Activities will include, but are not limited to, leading the document change control process, distributing, and maintaining documents and records both manual and within the Electronic Quality Management System (eQMS).
At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.
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Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity! Key Responsibilities.
Oversee the complete document lifecycle, including creation, review, approval, distribution, training, retrieval, and obsolescence to ensure full compliance.
Reviews, edits, and formats, controlled documents according to approved procedures and templates, monitors document status and approval notifications, distribution and archiving.
Review new and revised controlled documentation for appropriate format, content and consistency with other documentation and compliance to document control procedures.
Collaborate with cross-functional departments to ensure timely implementation of document change requests and change control associated tasks.
Ensure the management of controlled documents are processed in a timely manner while safeguarding quality, accuracy and adherence to company and regulatory requirements.
Support improvement initiatives to strengthen document management processes and systems.
Qualifications Education.
A minimum of a Bachelor's degree is required.
Experience and Skills.
Required.
Minimum of 2 years work experience providing document management and record control in an FDA/ISO regulated environment.
Preferred.
Knowledge of U.
.
FDA medical device regulations (21 CFR 820) and/or International Standards (ISO ).
Experience using electronic Quality Management System solutions in a regulated environment.
Other.
Strong interpersonal skills, ability to work in a team environment, attention to detail, and excellent problem resolution skills.
The anticipated base pay range for this position is $ to $.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs.
medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits.
Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on Company benefits, please go to https://www.
areers.
nj.
om/employee-benefits This job posting is anticipated to close on .
The Company may however extend this time-period, in which case the posting will remain available on https://www.
areers.
nj.
om to accept additional applications.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.