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Product Compliance Certification Lead

2 months ago

Royal Oak, Michigan, United States Quanta US Full time
Job Overview

Quanta US is in search of a proactive Product Compliance Certification Lead to join our esteemed client, a prominent entity in the manufacturing of filters and components. This role is pivotal for the Safety division, focusing on compliance with Personal Protective Equipment (PPE) and Respiratory Protective Equipment (RPE) regulations and standards such as EN 140, EN 166, and NIOSH. If you possess a robust background in Product Certification or Product Development, this position offers a chance to spearhead compliance and quality initiatives.

Key Responsibilities:

  • Oversee the Certification Program for PPE products.
  • Develop and maintain product Technical Documentation and Technical Files.
  • Participate in Regulatory and Certification Audits.
  • Engage with notified bodies and regulatory agencies, fostering strong professional relationships.
  • Ensure ongoing product compliance for regulated items, including managing certification renewals and coordinating testing with internal and external laboratories.
  • Support the design engineering team with regulatory guidance for product modifications and new developments.
  • Assist in resolving product quality concerns.

Purpose of the Role:

  • Supervise the upkeep of active product certifications.
  • Collaborate with the Design Engineering Team for new product approvals.
  • Maintain and update existing certifications and approvals.
  • Manage technical files and regulatory documentation effectively.
  • Provide regulatory assistance to the design engineering team.
  • Support the quality team regarding certified products.

Qualifications:

  • Demonstrated experience in managing multiple projects simultaneously.
  • Familiarity with certification applications to notified and approval bodies.
  • Experience in PPE and RPE is preferred.
  • Knowledge of Quality Management System processes (ISO 9001:2015, ISO 45001:2018) is advantageous.
  • Understanding of PPE/RPE regulations and standards or similar regulatory frameworks.
  • Experience with supply chain activities for regulated products.

Educational Background:

  • Bachelor's Degree or equivalent in a relevant field such as science or engineering.
  • Experience in Product Design, Industrial Design, or Design Engineering is beneficial.

Experience Requirements:

  • Minimum of 3 years in product certification within a related industry, which may include sectors like PPE, Medical Devices, Automotive, or Aerospace.

Detailed Responsibilities:

  • Lead certification development projects from initial quotation through to delivery, consistently evaluating project objectives and product compliance within the established Project Management Process.
  • Achieve necessary certifications and approvals for newly developed products.
  • Update and sustain existing certifications and approvals, adapting to product and documentation changes as required.
  • Maintain and manage technical files and regulatory documentation.
  • Provide regulatory support and insights to the Design Engineering team.
  • Communicate with regulatory agencies to monitor changes and address compliance inquiries.
  • Organize and oversee required product testing for development and certification.
  • Ensure accurate and comprehensive records are maintained in accordance with company standards and quality requirements.
  • Adhere to all relevant procedures and processes as outlined in the company’s quality management system.
  • Offer specialized support to the Quality Assurance team.

Essential Personal Attributes:

  • Team-oriented with a strong sense of accountability.
  • Positive and enthusiastic demeanor.
  • Ability to prioritize and manage multiple tasks effectively.
  • Consistent in following detailed procedures.
  • Adaptable to changes in priorities and project direction.
  • Willingness to travel for business as necessary.