Quality Operations Manager

Terumo Aortic; Town of Florida (NY); On-site; USD 90,000 - 120,000; Full time

Job summary

Terumo Aortic is looking for a Quality Assurance Manager in Florida, NY. The successful candidate will lead the quality operation staff, ensuring compliance with ISO standards and managing nonconforming events. The role requires strong leadership with 8+ years in QA or manufacturing within a regulated environment.

Qualifications include a bachelor's degree in Engineering or Quality Engineering, alongside significant experience in medical device processes. Applicants should exhibit excellent communication skills and an ability to influence others while promoting a quality-driven culture.

Qualifications

• 8+ years of related experience in a regulated Quality Assurance environment.
• Understanding of medical device design and process controls per FDA QSRs and ISO 13485.
• Experience handling nonconforming events.

Responsibilities

• Manage Production Quality staff and oversee QA processes.
• Identify and monitor nonconforming events.
• Perform product failure investigations and implement corrective actions.
• Interact with cross-functional teams to resolve quality issues.
• Support CAPA system and address compliance issues.

Skills

Communication skills

Organizational skills

Leadership ability

Influencing others

Ability to multitask

Education

Bachelor's degree in Engineering or Quality Engineering

Job description

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Responsible for supporting the quality operation staff in the receiving inspection, in-process and finished product and maintaining processes and methods in accordance with the company standards. Reporting on the performance of the assigned quality areas. Management of QA/QC staff, GMP and ISO compliance.

Key Duties

• Manages Production Quality staff overseeing Receiving Inspection, Cleanroom, and Final Release areas, including all inspectors, analysts, and technicians that report into the supervisors of those areas.
• Identifies, Reports and Monitors Nonconforming events for the Receiving, Cleanroom, Final Packaging and Release areas.
• Performs product failure investigations and implements corrective and preventive actions to prevent reoccurrence.
• Interacts with cross-functional teams to resolve quality issues.
• Quality Control, product release authorizations, and quarantine of all suspect or discrepant product.
• Develops Quality Instructions and Quality Standards.
• Support in the development, validation, and implementation of Test Methods.
• Reviews and approves engineering changes to support product life cycle.
• Provides adequate QA support to the assigned areas and responds to Internal Audits, and takes actions as appropriate based on CAPAs, Complaints investigations, Nonconforming events, etc.
• Supports the Corrective and Preventive Action (CAPA) System.
• Identifies and evaluates fundamental compliance issues for major functional areas through assessment of quality system compliance.
• Establishes Quality Assurance objectives and assignments, and delegates assignments to subordinates.
• Involved in executing company policies.
• Recommends decisions on administrative or operational matters and ensures Quality Assurance(s) effective achievement of objectives.

Quality Requirements

Ensure compliance with all quality systems regulatory requirements such as, but not limited to, ISO 13485, 21 CFR Part 820, MDSAP, MDD (93/42/EEC) and MDR (EU 2017/745)

Responsible for addressing issues within the QMS without undue delay as evidenced by on time completion of actions on the Single Action Tracker (SAT)

EH&S Requirements

Create a safety culture and safe working environment.

Ensure compliance with all Environmental Health and Safety regulatory requirements.

Provide recourse to meet Environmental Health and Safety goals.

Maintain defined organization Environmental Health and Safety competencies.

Ensure related Risk Assessments are completed, accidents raised and action hazards.

Qualifications & Experience

Minimum Skills & Capabilities:

• Works with all levels within the company.
• Strong communication skills (written and oral)
• Ability to organize and conduct multiple, parallel tasks.
• Ability to seek and utilize varied resources.
• Ability to influence others.

Minimum Knowledge & Experience required for the position:

• A bachelor’s degree or equivalent experience in Engineering, Quality Engineering or Sciences.
• Understanding of medical device design and process controls per FDA Quality System Requirements (QSRs) and ISO 13485.
• Understanding of required standards / regulations impacting Medical Devices.
• Leadership ability and organizational skills.
• Strong team-oriented professional with good interpersonal skills who is hands-on with a high energy approach to work.
• 8+ years of related experience in a regulated environment in Quality Assurance and or Manufacturing/ Engineering environment.
• Must have experience handling nonconforming events.
• Packaging/Labeling process experience is a plus.