- Provide quality support and oversight (approval) of compliance and audit readiness activities related to a TPM,
- Ensure that processes, equipment, and procedures used in the support of the Quality System are maintained in compliance with applicable regulatory, local site, and Abbott requirements,
- Review documentation (including but not limited to audit observation responses, change control records, investigations, etc.) for accuracy, clarity, consistency, completeness, and compliance,
- Plan and complete assignments with a wide degree of difficulty while maintaining milestones established in the project schedule,
- Analyze data, procedures, and requirements to ensure quality and compliance,
- Collaborate with alternate functional teams (including but not limited to engineering, operations, regulatory, program management, and other quality teams) to ensure consideration is given to financial and business outcomes when making quality decisions,
- Coordinate activities across multiple project groups,
- Accept ownership and responsibility for decisions,
- Effectively engage with team members within Abbott and TPM teams, and
- Provide guidance, coaching, and training to various functions and colleagues.
- Lead quality compliance projects to ensure that equipment, systems, procedures, & processes are compliant and consistent with Abbott and external (e.g. regulatory, standards, etc.) requirements.
- Support the TPM in ensuring audit-readiness activities.
- Ensure adherence and support maintenance of the effectiveness of the Quality System, including the Subsystems and Key processes by promptly addressing non-compliance issues.
- Demonstrate good, general understanding of the standards and regulatory bodies that regulate the medical device industry when making decisions and leading projects.
- Provide solutions to a wide range of difficult problems and implement tactical solutions which meet compliance and business needs.
- Recognize project interdependencies and with minimal oversight, lead complex quality discussions across various departments including, as needed, external suppliers.
- Take responsibility & accountability for defining project goals and milestones as well as timely project completion.
- Communicate confidently and effectively with management, peers, and key stakeholders.
- Lead quality projects with cross-functional team or broader scope (e.g. multi-site scope), as assigned.
- Directly influence project direction and scope.
- Work independently with objectives given by the Quality Manager.
- May represent own team while on cross-functional project teams with other functional leaders.
- Identify areas for process improvement and provides supporting information for change, including reasons and justifications.
- Assist team members and cross functional colleagues in meeting their goals by providing training, coaching, and/or mentoring, as needed.
- May provide oversight to one or more QA professionals and/or contractors.
- Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
- Support projects and Divisional initiatives as identified by management.
- Performs other related duties and responsibilities, on occasion, as assigned.
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Senior Specialist Quality Assurance - Austin, United States - Abbott
Description
The Opportunity
This position works out of our Austin, TX location in the Diabetes Care division. We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.
This is an on-site daily position
What You'll Do
As the Senior Specialist Quality Assurance, you will be responsible for conducting and completing quality-related activities to support a third party manufacture (TPM) maintain compliance with Abbott, internal, and external requirements.
MAIN PURPOSE OF ROLE
This position is responsible for providing quality support and oversight on quality compliance related activities supporting a TPM. Specifically,
MAIN RESPONSIBILITIES
Education/Experience
Required Qualifications
Bachelors Degree In Life Science, Engineering, or closely related discipline or an equivalent combination of education and work experience
Minimum 5+ years In Quality or related field experience; Less experience may be appropriate with advanced degree.
Preferred Qualifications
Quality experience in the medical device or pharmaceutical manufacturing industries.
History of completing successful projects and driving positive compliance outcomes.
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