maintenance of controlled documentation and records, maintenance of documentation databases and enforcing adherence to written documentation policies and procedures.
MAIN RESPONSILIBILTIES
Assure Effective Change Order Administration.
Ensure that all change requests comply with procedure requirements.
Coordinate and control the processing of all documentation change requests, procedures, and appropriate documentation.
Coordinate implementation of change requests with all affected areas/facilities.
Prioritize and schedule completion of approved change orders
Work with remote facilities as necessary to assist in changes that affect multiple locations.
Maintain appropriate logs and records.
Provide assistance to change requestors in updating documents, creating or updating Bills of Materials and submitting change requests etc.
Maintain accurate configuration control
Control part numbers and revision level assignments. Maintain product configurations by ensuring accuracy of Bills of Materials.
Control Device Master Records. Maintain item master accuracy by updating additions, deletions, and other changes as required.
Assure effective documentation control administration
Monitor and prioritize routine documentation activities and requests to ensure customer expectations are met.
Distribute notifications and updated documents to applicable areas, as required.
Proofread documents for accuracy and adherence to policies, as necessary.
Provide technical support to Engineering projects
Support Engineering projects to ensure accurate product configuration and documentation of new products.
Support project teams to ensure change requests are implemented to meet deadlines.
Support Custom Device Requests to ensure accurate documentation, as necessary.
Miscellaneous: Create change orders for personnel as requested. Provide support to archiving activities.
Support Customer requests such as; retrieval of old history including down rev. documents and device history, provide copies of procedures and/or procedure books as necessary, update distribution lists etc.
Evaluate activities and identify areas of improvement and carry out improvement activities.
Support all Company initiatives as identified by management and in support of Quality Management
Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements,
Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
QUALIFICATIONS
Education
High School Diploma / GED
Experience
Experience Details
Minimum 4 years 4-5 years related worked experience.
Solid computer skills and report writing skills. Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to maintain regular and predictable attendance.
Apply Now
Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
- The base pay for this position is
- $20.25 – $40.55/hour
- In specific locations, the pay range may vary from the range posted.
JOB FAMILY
Operations Quality
DIVISION
CRM Cardiac Rhythm Management
LOCATION
United States > Sylmar : 15900 Valley View Court
ADDITIONAL LOCATIONS
WORK SHIFT
Standard
TRAVEL
Yes, 5 % of the Time
MEDICAL SURVEILLANCE
Not Applicable
SIGNIFICANT WORK ACTIVITIES
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
