Manager, Regulatory Affairs and Compliance

Job Summary

A high-performing individual to provide hands-on leadership to the Finished Device Solutions (D&D) team, and to be a key individual in the areas of Quality Management.  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

Qualifications

• An experienced individual to provide hands-on leadership for the Manufacturing (D&D) team, who will champion the Nordson MEDICAL New Product Introduction (NPI) Process.
• A committed individual with working knowledge of Medical Device Manufacturing and a proven track record of scaling processes and systems to meet business growth needs.
• A professional with expertise in Regulatory Compliance knowledge for the applicable regulatory requirements to support our customers for the Design Control and Manufacturing activities.
• This individual will work closely with the Operations and Engineering team leadership to drive and grow the business to meet the strategic objectives of the organization.
• This person will possess the strategic skillset to develop the plans and structure to ensure successful growth without compromising regulatory compliance or quality standards.

Responsibilities

• Fully proficient degreed-engineer considered the subject matter expert or "go-to" technical person that works on unusually complex, technical problems and provides solutions which are highly innovative and creative. 
• Has the ability to discern an appropriate course of action based upon multiple proposed solutions. 
• Typically lead large scale and technically complex projects or projects that have an ambiguous scope or project path, while demonstrating strong interpersonal skills that enable substantial cross-functional influence. 
• Regularly interact with the customer and have broad knowledge to understand what the customer wants even if requirements and direction are not clear. 
• Provide mentorship to engineers and manage teams, setting appropriate goals and giving direction.
• Has decision making skills to select the members of their team.
• Provide strategic project direction and ensure that technologies are up-to-date and identify technical gaps and takes action to address them.   
• Their work is performed without appreciable direction and they exercise considerable latitude in determining technical objectives of their assignments that they complete or delegate to their team.

Job Duties

• Provides technical support to Manufacturing and Product Engineering regarding validations, test method validations, and statistical analysis.
• Supports the planning, development, implementation and maintenance of manufacturing methods, processes, and operations for new and existing products as well as the design and manufacturing of new tooling and equipment.
• Supports the Value Stream Model for coordinating activities, including Continuous Improvement projects and management of Quality tasks.
• May conduct evaluation, approval and performance monitoring of suppliers.
• Ensures the identification, segregation, and disposition of nonconforming material and processes have been established for the facility.
• Provides sustaining Engineering support to resolve manufacturing issues in the plant and with the customer.
• Participate in/lead lean and cost reduction activities.
• Leads & conducts investigations and associated actions related to CAPA and Internal/external audit activities.
• Ensures that investigations and associated actions related to customer complaints are executed in accordance with procedures.
• Performs Internal audits as needed.
• May execute/host external audits.
• Maintains Quality System implementation with procedure and form maintenance and development.
• Provides training as subject matter expert in Quality Management and regulatory requirements.
• Ensures that all direct reports are efficiently utilized and billable at target levels.
• 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.
• 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 emphasis on Manufacturing Controls.
• 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 Operations / Manufacturing of Medical Devices preferred
• Experience with hosting FDA facility inspections is a plus

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
• Key areas of experience vital for this role:
  • Six Sigma
  • DFM/DFA
  • Lean Concepts
  • Human Error Defect Prevention

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.