Omnicell, Inc. Quality Complaint Manager in Cranberry Township, Pennsylvania

Quality Complaint Manager

Description

Quality Complaint Manager

The Quality Complaint Manager will ensure complaints are compliant with relevant medical device regulations, ensuring performance to Omnicell quality standards and regulatory requirements. Additional responsibilities include providing solutions for quality best practices, complex data analysis, reporting to regulatory agencies, and planning and executing quality management system training.

Responsibilities:

  • Evaluate complaints to determine whether the complaint represents an event which is required to be reported to regulatory authorities

  • Review and evaluate complaints to determine whether investigation is necessary. If necessary, facilitate and execute the investigation

  • Work alongside technical resources to investigate complaint and complete root cause investigation

  • Facilitate data analysis on complaint trending

  • Manage regulatory reporting to the appropriate regulatory authorities

  • Implement a corporate wide Quality Management System Training program

  • Manage and/or participate in CAPAs as required

  • Act as a liaison between Quality and other Omnicell functional departments

  • Lead or Participate in Quality Management Review meetings

  • Mentor internal complaint staff members

Required Knowledge and Skills:

  • Working knowledge of complaint management systems

  • Proven record of successful submissions to FDA

  • Demonstrated ability to effectively interface and communicate with multiple constituents, including senior management, customers, consultants, vendors, and employees of all level

  • Change agent who accepts and supports new ideas and processes

  • Strong written, verbal and presentation skills to all levels of an organization

  • Refined multi-tasking and time management skills

  • Ability to consistently balance sense of urgency with diplomacy/empathy

  • Ability to make decisions and execute directives

  • Strongly demonstrated organizational and project management skills with strong attention to detail

  • Ability to work under tight deadlines and handle multiple detail-oriented projects

  • Proficient with common MS office programs (Word, Excel, PowerPoint, Project)

  • Team builder, self-starter, organized, analytical and decisive

  • ISO 13485 QMS knowledge, preferred

  • FDA 21 CFR part 820, preferred

Basic Qualifications:

  • Bachelor's of Science Degree

  • Minimum of eight (8) years’ experience in a regulated environment

Preferred Qualifications:

  • Bachelor's degree in Technical discipline

  • Experience in a regulated FDA Medical Device environment

  • Working knowledge establishing and delivering corporate wide training programs

Work Conditions:

  • Office Environment

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

Omnicell will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.