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Search for Jobs by Sandy Bishop

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Senior Manager, Packaging Engineering & Labeling (Healthcare & Medical)
Boston, MA 01752
Recruited by: Sandy Bishop | Owner & President | F-O-R-T-U-N-E Personnel Consultants, Inc. See all my Jobs

  • Hiring Company: FPC of Boise
  • Industry: Healthcare & Medical
  • Compensation: Depends On Experience
  • Expires: Jul 10, 2017
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Job Description

Manage product labeling for the Urology and Pelvic Health (both Development and Sustained Engineering) to a level of quality our worldwide customers expect for device use. Responsible for leading the Packaging Graphics (labeling) support for product development, submissions and regulatory compliance.
Key Responsibilities:
● Support the Urology and Pelvic Health R&D Divisions with labeling technical expertise and execution of required product labeling components and accurate content requirements to meet both US and OUS regulatory requirements.
● Assists in and/or manages functional deliverables and ensures technical excellence for packaging, product or technical development.
● Support associated manufacturing sites for Urology and Pelvic Health with input to required technical changes of all product labeling and packaging elements.
● Support related OEM/Alliance Partner manufacturing for Urology and Pelvic Health with input to required technical changes of all product labeling and packaging elements.
● Participate in the Packaging Council, Labeling Council, and Master Brand Initiatives for review of corporate standards and the development of continuous improvement programs.
● Aid in root cause analysis for labeling issues (bar coding, label content, etc.) with all manufacturing facilities, OEM/Alliance partners, and distribution centers. Manage the New Product Design and Development team within the Urology and Pelvic Health Packaging Development group.
● Provides guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high quality staff.
● Generate validation and verification related documentation including specifications, test plans and reports, and other Product Development Process documents.
● Research, Assess and Develop new technologies and concepts related to Labeling and Packaging.
● Takes a leadership role in driving the packaging and labeling conversion of existing products into the new corporate branding. Works with packaging engineering and other functions to establish a core-team for the branding introduction. Extensive experience allows for involvement in procedural and policy decisions.
● Involved in management process of Translations and Content Management as a member of a corporate wide team.
● Responsibilities include strong competence at a high level of project management with a good understanding of regulatory and quality system requirements.
● Experience within a Corrective/Preventive action system is preferred.
Management Qualifications:
● Leads a group or team of employees, approximately 9, in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization.
● Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
● Directs and controls the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations.
● Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
Minimum Requirements:
● 3-5 years of management experience required
● BS in technical field required. MBA or MS preferred