Quality Assurance Engineer
ŌURA
QA Operations Manager
Abbott
full-time
Posted on:
Location Type: Office
Location: Sturgis • Missouri • 🇺🇸 United States
Visit company websiteSalary
💰 $127,300 - $254,700 per year
Job Level
SeniorLead
About the role
- Manage subordinate QA groups within the Sturgis, MI manufacturing plant with focus on ensuring accuracy of quality documentation.
- Oversee new product registrations, change management of existing documentation, batch record review, and product release.
- Set strategy for areas of responsibility to maintain best practices for quality document control.
- Perform detailed end-to-end review of all batch documentation to ensure compliance with policies, procedures, and regulations, including CAPA, interventions, and environmental monitoring data prior to batch release.
- Accountable for Batch Release Process Management: identify batch non-conformances, initiate appropriate actions, control release of product to market, and coordinate quarantine of nonconforming finished products.
- Maintain batch release, discrepancy, and non-conformity metrics and track MSP performance with other site departments.
- Review and approve all change requests to site-related documentation and assess Corporate and Divisional policy updates; partner with affected groups to ensure change control and updated site training.
- Manage new product introductions, label copy adherence, and product certification.
- Maintain the site Documentation system and QA Work Order systems; ensure QA documents meet Abbott and regulatory standards and are stored effectively.
- Identify gaps in Plant Documentation and systems and take necessary corrective actions.
- Executive leadership responsibilities: set strategy for teams, employee development, and effective change management related to quality documentation.
Requirements
- Bachelor's degree in a scientific or technical discipline.
- 7+ years of experience in a function or related field.
- 4+ years of direct supervisor experience.
- Must have demonstrated solid knowledge and experience in the discipline; considered a Subject Matter Expert and key contributor to initiatives.
- Leadership experience: leader and key contributor to initiatives and advancement of the Quality organization.
- Ability to make decisions and chart a course through careful evaluation of risks and benefits with limited information in conjunction with the Site QA Director.
- Builds/drives relationships and teamwork within the team and across functions with a professional demeanor.
- Accountable for meeting compliance standards including FDA, OSHA and Abbott policies and procedures.
- Must verify identity and eligibility to work in the United States upon hire (I-9 employment eligibility verification).
- Willingness to travel up to 5% of the time.
Benefits
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- FREE coverage in the HIP PPO medical plan for participants who complete a short wellness assessment.
- An excellent retirement savings plan with a high employer contribution.
- Tuition reimbursement.
- Freedom 2 Save student debt program.
- FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- Health and wellness benefits (learn more at www.abbottbenefits.com).
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality documentationbatch record reviewchange managementCAPAenvironmental monitoringbatch release process managementdiscrepancy metricsnon-conformity metricsdocumentation system managementQA Work Order systems
Soft skills
leadershipdecision makingrelationship buildingteamworkemployee developmentchange managementstrategic planningcommunicationprofessional demeanorrisk evaluation
