Manager, Quality Assurance & Regulatory Affairs in Manchester, NH at Tecomet

Date Posted: 5/28/2019

Job Snapshot

Job Description

JOB SUMMARY:

The Manager of Quality Assurance and Regulatory Affairs provides overall company leadership and direction to meet customer quality requirements, create, monitor and improve quality programs, reduce quality costs and maintain compliance within FDA and ISO regulations for the Manchester NH facility.  This is accomplished by maintaining Tecomet’ principles of Safety, Quality, Customer Satisfaction and Innovation.

ESSENTIAL FUNCTIONS:

Regulatory:

  • Perform regulatory evaluations on new products and product changes and create LTFs as applicable.
  • Maintain 510K and technical files.
  • Perform regulatory reviews of internal and customer co-development design files to approve for release.
  • Participate as design team member in product development projects.
  • Assure domestic and international regulatory requirements are considered in all facets of the quality management system.
  • Facilitate required design validation and testing based on intended applications.
  • Facilitate field complaint investigations and reporting.
  • Responsible for all domestic/international medical device import/export distribution submissions and associated maintenance.
  • Facilitate and maintain domestic/international regulation certificate submission and maintenance.
  • Apply and maintain licenses for all countries in which facility markets, distributes or manufactures.
  • Facilitate any necessary regulatory training internally or externally.
  • Oversee/facilitate Design and Development quality & regulatory requirements, which encompass all of design control, Medical Device Listings with the FDA and other affected international governments, vigilance/medical device reporting, Declarations of Conformity.

Quality:

  • Promote and develop plans with customers to certify Tecomet as a preferred supplier.
  • Assure consistent controls in the manufacturing process for continuous quality improvement and the reduction of quality costs.
  • Participate in Material Review Board process.
  • Coach and train Quality Engineers, Six Sigma Green Belts and Quality Inspectors.
  • Direct Six Sigma initiatives.
  • Lead internal & external audits and manage supplier quality programs.
  • Develop global Quality and Manufacturing standard operating procedures and related improvement plans.
  • Measure the effectiveness of the systems in place, report back to upper management and develop assessments and corrective action plans.
  • Oversee special processes validations and gage control. Review and approve special process validations and revalidation verifications.
  • Facilitate the CAPA program.
  • Records retention/archive management.
  • Project a positive and professional image of the company and of management to employees at all levels.
  • Responsible to handle human resource responsibilities in a fair, consistent, unbiased, confidential and positive manner while abiding by all laws, policies and procedures.
  • Responsible for timely performance reviews.
  • Additional functions and requirements may be assigned by manager as deemed appropriate.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Strong knowledge of  Medical device FDA QSRs, ISO 13485, Technical Files, CE Marking (MDD), and international registrations of medical devices.
  • Experience with 510(k) submissions for class II devices. 
  • Versed in regulatory requirements for all countries, including but not limited to: US FDA, EU MDD, Japan PAL, Canada, etc.
  • Highly organized and self-motivated to complete projects on time; leader for multiple quality improvement initiatives.  
  • Ability to communicate professionally to common inquiries or complaints from customers, or regulatory agencies.
  • Ability to define problems, collect data, establish facts, and interpret technical instructions.
  • Ability to read, analyze, and interpret common scientific and technical journals, technical procedures, quality documents and/or government regulations.
  • Ability to apply advanced mathematical concepts and apply mathematical operations to determine such tasks as test reliability and validity, correlation techniques and factor analysis.
  • Ability to effectively present information and respond to questions from teammates, direct reports, management, and internal and external customers.
  • Proficient in Microsoft Office Suite.
  • Strong knowledge in manufacturing operations.
  • Lean manufacturing experience.
  • Ability to multi-task and prioritize work.
  • Is able to communicate at all levels of the organization.
  • Is flexible and is able to adapt to changes in the market place.
  • Create and manage high performing work teams.
  • Identify and make process improvements.
  • Meet goals and objectives set for department and company.
  • Keep current in changing work methods and regulatory changes.
  • Make decisions in a consistent, professional manner.

EDUCATION AND WORK EXPERIENCE:

  • Minimum Bachelor of Science degree in an Engineering, Science or Regulatory-related field.
  • Minimum five years of experience in an exempt regulatory/quality position in the medical device industry.
  • Minimum 3 years manufacturing experience.
  • ISO/FDA lead auditor certification preferred
  • ASQ CQE and/or CQA, CQM certification preferred.

PHYSICAL AND ENVIRONMENTAL DEMANDS:

  • Well lighted, heated/or air-conditioned indoor office/production setting with adequate ventilation.
  • Light physical activity performing non-strenuous daily activities of a primarily administrative nature.
  • Ability to maneuver throughout the facility/facilities as needed.
  • Manual dexterity sufficient to reach/handle items and work with fingers.
  • Ability to wear proper PPE.

Tecomet is an Equal Opportunity Employer M/W/VET/DISABLED