The Senior Quality Engineer will develop, establish, and maintain quality engineering practices which meet Agiliti, customer, and regulatory requirements.

PRIMARY DUTIES AND RESPONSIBILITIES

Senior Quality Engineer

• Participate in all applicable Quality Management System (QMS) activities including document change management, records management, training/competency, non-conforming material reports (NCMRs), Complaint/Incident investigations and Corrective and Preventive Actions (CAPAs)
• Maintains and reviews product and process risk analysis.
• Develops and maintains product inspections plans.
• Reviews and approves change management activities.
• Lead quality activities related to sustaining engineering changes and documentation including, but not limited to areas such as: risk assessment, device traceability, labeling regulations, process/product/software validations, acceptance activities/inspection criteria, and maintenance of device master records.
• Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Ensures compliance with internal and external regulatory agencies.
• Ensures that corrective measures meet acceptable standards.
• Applies statistical methodologies for assessment and to resolve potential product and quality system issues.

• Stay abreast of applicable industry standards
• Work independently; minimal daily direction required to successfully develop deliverables.

• Independently identifies quality issues and/or trends
• Defines and completes quality tasks necessary to achieve compliance and/or product specification compliance.
• Guides, supervises, and or/coaches others on the quality team. May supervise a team.
• Active in professional quality organizations or other means by which to maintain current on Quality trends
• Identifies quality issues and/or trends and leads change.
• Creates and maintains project schedules and delivery milestones for completion.

REQUIRED EXPERIENCE

• Senior Quality Engineer: Bachelor's degree in Engineering or life sciences required. Electrical Engineering a plus.
• Minimum 5 - 8 years Quality Engineering experience OR advanced degree with 5 years of applicable experience.
• Experience in ISO 13485, 21 CFR Part 820, and Medical Device Manufacturing.
• Experience guiding and coaching others.
• 3 years of experience leading quality/new product development projects,
• Experience improving and maintaining an effective Quality Management System.
• Ability to speak and write in Spanish highly desired.

REQUIRED SKILLS & ABILITIES

• Proficient computer skills in MS Office Suite
• Comprehensive understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
• GD&T experience.
• Strong analytical skills including application of statistical techniques.
• Strict attention to detail
• Strong technical writing skills and effective communication skills
• Strong presentation, facilitation, and project management skills

This job description in no way states or implies that these are the only duties to be performed by the employee in this position. It is not intended to give all details or a step-by-step account of the way each procedure or task is performed. The incumbent is expected to perform other duties necessary for the effective operation of the department.

It is the policy of Agiliti to provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender identity, sex, sexual orientation, national origin, age, physical or mental disability, genetic information, marital status, status as a veteran, military service, or any other characteristic protected by applicable federal, state, or local civil rights laws.In addition, Agiliti will provide reasonable accommodations for qualified individuals with disabilities. Agiliti strictly prohibits any form of retaliation against individuals who make good faith reports of alleged violations of this policy or who cooperate in Agiliti's investigation of such reports.

You may be required to obtain certain vaccinations, or provide proof of current vaccination status, based on customer and/or company requirements. If vaccination is required, Agiliti will provide specific directions and cover the expense at a participating clinic. Please note, this includes the COVID-19 vaccination.

Agiliti offers a robust suite of benefits for regular, full-time, non-union employees including: health insurance options for Medical, Dental & Vision plans, Short- and Long-Term Disability plans, Flexible Spending Accounts, Health Savings Accounts, Life Insurance Options, Paid Time Off, 401K Saving Plan with employer match, Employee Discounts, Tuition Reimbursement, Daily Pay program, Employee Assistance Program, Employee Stock Purchase Program (ESPP) and wellness programs.

Agiliti is an equal opportunity employer and provides reasonable accommodations to employees and applicants consistent with state and federal law.

Agiliti

This range represents the low and high ends of the Agiliti pay range for this position. This base pay range information is based on the market locations shown. The actual pay offered may vary depending on several factors including geographic location, experience, job-related knowledge, skills, and related factors. Dependent on the position offered, short-term and/or long-term incentives may be provided as part of the compensation. Applicants should apply via Agiliti's internal or external career site.