Senior Supplier Quality Engineer

The Senior Supplier Quality Engineer will develop, establish, and maintain supplier quality management practices that meet Agiliti, customer, and regulatory requirements.

PRIMARY DUTIES AND RESPONSIBILITIES

Senior Supplier 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)
• Participates with quality members in the product development processes and documentation including, but not limited to supplier new product qualification and supplier development process.
• Execute tasks associated with continuous improvement activities.
• Provides data for predefined metrics for supplier monitoring.
• Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Ensures compliance with internal and external regulatory agencies.
• Facilitates accurate and timely completion of customer and quality records.
• Ensures that supplier corrective measures meet acceptable standards.
• Applies statistical methodologies for assessment and to resolve potential product and quality system issues.
• Leads small projects within team or across one to two departments
• Work independently; minimal daily direction required to successfully develop deliverables
• Leads qualification of supplier selection and approval process
• Guides, supervises, and or/coaches others on the quality team. May supervise a team.
• Creates and maintains project schedules and delivery milestones for completion.
• Up to 50% travel required, with opportunity to plan travel schedule

REQUIRED EXPERIENCE

• Senior Supplier Quality Engineer: Bachelor's degree in Engineering or life sciences required.
• Minimum 5 - 8 years Quality Engineering experience OR advanced degree with 3 - 5 years of applicable experience.
• Experience with ISO 13485, 21 CFR Part 820, and Medical Device Good Documentation Practices.
• Experience guiding and coaching others.
• 3+ years of experience leading supplier quality management and new product development projects, Experience improving and maintaining an effective Quality Management System.

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
• 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. Affirmative Action Policy Statements

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, 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.