Quality Operations Manager

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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 109,000 colleagues serve people in more than 160 countries.

STRUCTURAL HEART DIVISION

From transcatheter and surgical valves to structural interventions, the Abbott Structural Heart portfolio spans a wide range of life-changing technologies. Abbott is at the forefront of transforming structural heart therapies, leading the development of more advanced solutions for patient care.

As a passionate, committed, and innovative team, we strive to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of Structural Heart disease. We aim to lead the markets we serve by requiring our products provide customers an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.

WHAT YOU'LL DO

We are seeking an experienced Staff or Manager Quality Assurance/ Quality Engineer to join our SH team in our Saint Paul, MN location. The individual in this position will assure our products conform to requirements and establish compliance with the quality system. This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by ensuring product is manufactured to the highest standards. This position will support operations as a lead with direct reports underneath them.

This position will be responsible for the day to day direction of their direct reports, and requires exemplary motivation, communication, and organizational skills. Provides technical leadership to the business unit and participates in the development of other technical contributors by facilitating training and providing feedback and guidance. This individual will have a unique opportunity to make a mark on the organization as a leader by creating, developing and managing an effective team environment, while working on state -of-the art products.

Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
  • Non-Conforming Material Reports (NCMR) including; root cause investigation, risk assessment, historical record review, disposition strategy, correction activities.
  • Complaints Reviews/Manufacturing Analysis/Field Impact Escalation including; event assessment, root cause investigation, risk assessment, historical record review, impact/action escalation.
  • Corrective Action Preventive (CAPA); including root cause investigation, scoping/bracketing, resolution planning, implementation, and verification of effectiveness.
  • Regulatory requests including; certification of compliance and product inquires.
  • Manufacturing/Production Line Support - partnering with operations team members to achieve value stream goals and objectives.
  • Change Control - review documentation change orders per quality system requirements using PLM system.
  • Validation/Qualification - Lead/review Installation Qualification, Process Qualification, Operational Qualification, Product Performance Qualification (PPQ), Master Validation Plan/Report, and Test/Inspection Method Validation.
  • Risk Management - use and interpret Hazard Analysis, Failure modes and Effects Analysis.
  • Support back and front room during audits.
  • Line Reviews - facilitate line reviews / audits to find areas of continuous improvement
  • Maintain high standards for Device History File (DHF) content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating & resolving gaps.
  • Identify and drive opportunities to improve the quality system
  • Act as a mentor to cross functional teams as well as less-experienced staff and may provide work direction or supervise other technical employees.
  • Writes and revises SOPs, controlled forms, and related documents to ensure best practices and alignment with current operations.


EDUCATION AND EXPERIENCE YOU'LL BRING

Required
  • Bachelor's Degree within an Engineering field or related science-based discipline
  • 9+ years of related work experience in a Quality Engineer function and/or working in a quality system environment
  • Previous experience working in a highly matrixed and geographically diverse business environment with the ability to leverage and/or engage others to accomplish projects.
  • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
  • Proven experience exercising judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business.
  • Excellent verbal and written communication skills, with ability to communicate to all levels of the organization

Preferred
  • Advanced degree in a technical field
  • Medical device experience, specifically working with valves and/or implantable devices
  • Prior experience working with any or all of the following:
    • ISO 13485 Medical Devices - Quality Management System
    • 21 CFR Part 820 FDA Quality System Regulations
    • ISO 14971 Medical Devices - Application of Risk Management
    • EUMDR
    • MDSAP
    • Good Manufacturing Practices and Good Documentation Practices

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a generous company match
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspx

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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.

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