Lead a team of inspectors and technicians to ensure quality inspections and compliance with regulatory standards in the medical industry.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
MAIN PURPOSE OF THE ROLE
Provide leadership to inspectors and technicians that support receiving, in-process and final inspection, tool inspection/qualifications and first article inspections.
MAIN RESPONSIBILITIES
- Assure timely inspections that support materials, product releases and in-process inspections.
- Maintain staff and equipment to assure appropriate technical capabilities.
- Monitor inspection procedures for effectiveness.
- Monitor compliance to appropriate regulatory standards.
- Effectively communicate with and provide support to other departments as necessary.
- Maintain a department culture of continuous improvement.
- 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
Associates Degree (± 13 years) or Bachelor's preferred or an equivalent combination of education and work experience.
EXPERIENCE/BACKGROUND
- Minimum 5 years of Quality supervisory experience in medical industry and Quality systems auditing experience desired.
- ASQ certification in quality, six sigma, and/or lean manufacturing is desired.
- Experience working in a broader enterprise/cross-division business unit model preferred.
- 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 travel approximately 15-25%, including internationally.
The base pay for this position is
$81,500.00 – $141,300.00In 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, 15 % 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
Top Skills
Asq Certification
Environmental Management Systems
Fda Regulations
Lean Manufacturing
Quality Management Systems
Six Sigma
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