Sr. Manager, Quality
Company: Alphatec Spine
Posted on: August 8, 2022
DescriptionThis role will be Quality site lead responsible for
management of Quality Control, Quality Engineering and Quality
Assurance functions. This role will ensure freedom to operate,
maintenance, and improvement of the Quality Management system for
the distribution siteRequirementsESSENTIAL DUTIES AND
- Identify and execution mitigations to Local, Federal, and
International medical device requirements. Support and prepare for
- Oversight of Operations procedures for QMS and Regulation
- Manage budget for Quality functions within site.
- Develop and implement International Distribution procedures in
conjunction with Carlsbad support team.
- Lead cross-functional teams in the execution of process
- Recruit, train, and coordinate work of Quality staff.
- Manage Non-Conformances, CAPAs, and Complaint Investigations in
conjunction with Carlsbad support team as needed.
- Identify, procure, install, and validate needed equipment.
- Manage incoming Quality Control inspections for accuracy and
- QC lab maintenance, and continuous improvement initiatives
- Manage site Calibration needs.
- Manage Document Control tasks (scanning and uploading, record
- Manage any 3rd party resources.
- Other duties as assigned.Supervisory ResponsibilitiesManages
supervisors and coordinates the activities and responsibilities of
entire Quality department.QualificationsThe requirements listed
below are representative of the knowledge, skill, and/or ability
required. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential functions.
- Strong management and interpersonal skills needed.
- QC, Calibration, NC, CAPA, SCAR, Quality Engineering
- Operations compliance experience (recall administration, lot
- Equipment Validation (IQ/OQ/PQ) knowledge required.
- FDA, ISO, QSR, knowledge required.
- 3+ years supervisory experience required.
- Advanced knowledge of Microsoft Office Suite and Outlook.
EDUCATION And/or EXPERIENCEBachelor's degree; or equivalent
experience required. 8+ years of experience in a medical device
manufacturing environment in a Clinical, Quality or Regulatory
Affairs role. 2 - 4 years of management experience.Benefits
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k, IRA)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
- Family Leave (Maternity, Paternity)
- Short Term & Long Term Disability
- Free Food & Snacks
- Stock Option Plan
Keywords: Alphatec Spine, Memphis , Sr. Manager, Quality, Executive , Memphis, Tennessee
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