• Job Description

  Req#: JR39567

  POSITION SUMMARY

  The Senior Director of Quality Operations is responsible for defining the Quality Management System for the manufacturing and design organization in accordance with applicable regulations and overseeing Post Market Surveillance activities. The Senior Director of Quality Operations will have oversight of product design and development processes, manufacturing plant quality processes, quality-related engineering activities, field corrective actions, and regulatory updates.

  PRIMARY DUTIES AND RESPONSIBILITIES

  • Quality Management System: Oversee quality management system and activities including document change management, records management, training/competency, procedure content (quality system documents and inspection procedures), quality system management review.

  • Post Market Surveillance: Oversee post market surveillance/support including recalls, field corrective actions, complaints.

  • Product Design and Development: Provide oversight of product design and development processes in alignment with regulations and ownership of all associated quality activities, including risk management, verification, and validation activities.

  • Manufacturing Plant Quality: Oversee Agiliti manufacturing, plant quality processes and tasks, including, but not limited to incoming inspection, in-process inspection, and final product release.

  • Continuation Quality Engineering Activities: Oversee quality-related continuation engineering activities, including, but not limited to the engineering change order process.

  • Regulatory Updates: Update FDA and other regulatory bodies with registered products and facilities.

  • Training and Guidance: Train and provide guidance to employees regarding areas of responsibility.

  • External Audits: Participate in external audits of the quality management system.

  • Metrics Management: Manage metrics to demonstrate effectiveness regarding areas of responsibility.

  • Quality System Management Review: Manage Quality System Management Review for manufacturing.

  • Quality Management Representative: Act as Quality Management Representative for areas of responsibility in external audits conducted by regulatory agencies.

  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.

  REQUIRED EXPERIENCE

  • Bachelor’s degree in Quality Management, Engineering, Life Sciences, or Business. Advanced degree preferred.

  • Minimum 15+ years of experience in regulated medical device manufacturing and/or design setting or as an auditor with a regulated agency such as the FDA, BSI, or TUV required.

  • Experience implementing quality system based on ISO 13485 and/or 21 CFR Part 820 in a medical device setting required.

  • Experience in mentoring, coaching, and providing guidance required.

  • Minimum 13+ years of experience managing direct reports required.

  • Experience with FDA, BSI, and/or TUV audits required.

  REQUIRED SKILLS & ABILITIES

  • Strong familiarity with ISO 13485 and 21 CFR Part 820 required. Familiarity with and experience implementing 21 CFR Part 11 preferred.

  • Strong communication and presentation skills, including ability to communicate effectively at all levels of the organization.

  • Proficient computer skills in MS Office Suite.

  • Strong background in manufacturing, new product development, and verifications/validations preferred.

  • Ability to sit, stand, lift, bend and stoop numerous times throughout the day.

  • Flexibility in work schedule to meet department needs.

  • May require up to 75% travel.

  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.

  If you require assistance with your application, please contact recruiting@agilitihealth.com.

  Primary Job Location:

  Home Office (MO)

  Additional Locations (if applicable):

  Job Title:

  Senior Director of Quality Operations

  Company:

  Agiliti

  Location City:

  Not Applicable

  Location State:

  Missouri

  Pay Range for All Remote Locations:

  $112,479.97-$292,447.91

  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. For sales positions, this range combines the base salary and the target incentive pay. 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.

• About the company

  Agiliti is a medical equipment management and services company dedicated to helping healthcare organizations access, manage and maintain medical equipment.

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