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Manager, Quality and Regulatory - Nordson MEDICAL at Nordson Corporation

Posted in Other 30+ days ago.

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Location: Sunnyvale, California

Job Description:
Job Summary
A high-performing individual to provide hands-on leadership to the Product Design & Development (D&D) team, and to be a key individual in the areas of Quality Engineering. Medical device development and manufacture experience is essential. Injection molding experience is also a strong plus. The individual will possess a broad range of medical device quality skills and experience, a record of leading and participating with teams from product concept through validation and into manufacturing, as well as in-depth knowledge in several clinical and product areas. This individual will also play a key role in mentoring less experienced employees and must be self-motivated and excited by the prospect of working in a dynamic, entrepreneurial environment.

Essential Job Duties and Responsibilities
  • Team Player/Coach Committed
  • Plays a major role in meeting or exceeding customer project objectives.
  • Able to lead projects, directly contribute and/or provide guidance to others to establish clinical, pilot production and scale-up plans in New Product Introduction programs.
  • Ensures that all direct reports are efficiently utilized and billable at target levels.
  • Identifies, and supports the pursuit of, new business opportunities. Works collaboratively with Nordson MEDICAL sales personnel to close sales.
  • Participates in the organization and execution of interdepartmental activities to ensure the completion of projects on schedule and within budget constraints.
  • Interacts with customer and supplier companies in a professional manner; proactively communicates with them to ensure an ongoing two-way exchange of information.
  • Intervenes and contributes to successful resolution of technical issues when they arise.
  • When required, manages large or strategic Product Development projects. Prepares project plans that define phases, tasks, durations, resource assignments, and costs. Proactively communicates assignments to responsible individuals, ensures that tasks are completed within the planned time and reports project status to the project's client company.
  • Writes and/or reviews proposals for prospective projects. Ensures all proposals are professionally done and contain accurate technical content, costs and time estimates.
  • Ensures that all work satisfies the requirements of the company's Quality Manual, with particular emphasis on Design Control.
  • Experience with Injection Molding preferred.
  • Experience in Quality Project Leadership preferred.
  • Responsible for assuring product quality, safety and effectiveness, and conduct of failure investigations of customer complaints, as required.
  • Responsible for timely Corrective and Preventative Actions (CAPA), change control and notification, internal and vendor audits, product release, document control, design control process and design history files (DHF), device master records, etc.
  • Manage the resources of the Quality Department to ensure staff are selected and sufficiently trained to meet current and future work requirements. Work with staff in administering the performance management system to ensure development needs are met and feedback is provided on a regular basis. Ensure the proper application of Human Resource policies through recommendation and approval of Human Resource actions such as salary administration, disciplinary action, and paid time off.

Education and Experience Requirements
  • Degree in Engineering
  • Experience in medical device is essential, minimum ten (10) years, quality leadership desirable
  • Experience in Injection Molding preferred

Skills and Abilities
  • Excellent communication skills with ability to interface at all levels.
  • Ability to recruit and retain high caliber staff, developer of people through professional and personal mentoring.
  • Required proficiency in the management of Quality; team player focus.
  • Excellent computer skills

Working Conditions and Physical Demands
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Travel Required
Estimated 10-20%

Nordson Corporation provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law.

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.