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Quanta U.S., Inc.
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Product Certification Manager
2807 Samoset Rd Royal Oak, MI 48073 US
Job Description
Our client, a global leader in filter and component manufacturing is seeking a dynamic Product Compliance Certification Manager with expertise in working with PPE/RPE regulations and standards (EN 140, EN 166, NIOSH) to support their Safety division. If you have a solid background in Product Certification and/or Product Development, this is your opportunity to lead their Product Compliance and Quality initiatives. Benefit from a dynamic work environment, advanced technological skills, and a commitment to delivering exceptional service and support to our clients globally.
Main Responsibilities:
Job Purpose:
Experience:
Educational Requirements:
Experience Requirements:
Detailed Responsibilities:
Key Personal Qualities:
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Main Responsibilities:
- Manage the Certification Program for Personal Protective Equipment Products.
- Maintain & create product Technical Documentation/Technical Files.
- Take part in Regulatory & Certification Audits.
- Liaising with notified bodies and regulatory agencies (i.e. NIOSH) and building strong relationships.
- Maintain product compliance for regulated products, including certification renewals and internal/external test laboratory testing management.
- Provide regulatory support to the design engineering team for changes and new product development.
- Provide support with product quality issues.
Job Purpose:
- Oversee the maintenance of active product certifications.
- To work with the Design Engineering Team for the approval of new products.
- Update and maintain existing certifications and approvals.
- Control, update, and maintain technical files and regulatory documentation.
- Provide regulatory support for the design engineering team.
- Support the quality team in matters relating to certified products.
Experience:
- Proven experience in planning and managing multiple tasks.
- Experience with applications for certifications and approvals to notified and approval bodies.
- Desirable experience in Personal Protective Equipment (PPE) and Respiratory Personal Equipment (RPE).
- Desirable experience working within Quality Management System processes (ISO 9001:2015, ISO 45001:2018 etc)
- Desirable knowledge of PPE/RPE regulations and standards (EN 140, EN 166, NIOSH) or working within other regulatory standards.
- Experience with regulated products supply chain activities.
Educational Requirements:
- Bachelors Degree or equivalent in science, engineering, or equivalent experience.
- Background in Product Design, Industrial Design, Design Engineering, or equivalent.
Experience Requirements:
- 3+ years of product certification experience in a similar field – this can include Personal Protective Equipment, Medical Devices, Automotive, Aerospace etc.
Detailed Responsibilities:
- Manage certification development projects from quotation to delivery, continuously reviewing project goals and product conformity within the established Project Management Process.
- Achieve certification and approvals for newly developed products.
- Update and maintain existing certifications and approvals, including updates necessitated by product and documentation changes.
- Control, update, and maintain technical files and regulatory documentation.
- Provide regulatory support and advice to the Design Engineering team.
- Interact with regulatory agencies to track changes and address compliance questions and issues.
- Organize, plan, and control required product testing for development and certification.
- Ensure accurate and meaningful records are maintained in line with company practices and quality requirements.
- Adhere to all relevant procedures and processes as defined in the company quality management system.
- Provide targeted support to the Quality Assurance team.
Key Personal Qualities:
- A team player with personal accountability.
- Positive and enthusiastic outlook.
- Ability to multitask and effectively plan work.
- Consistency in following detailed procedures.
- Flexibility to handle changes in priority and project direction.
- Willingness to travel for business as required.
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Unlock Your Potential in Royal Oak, Michigan! Discover the exciting job opportunities in this vibrant city that blends urban sophistication with small-town charm. Nestled in Oakland County, Royal Oak boasts a thriving job market, a bustling downtown featuring a variety of shops, restaurants, and entertainment venues including the iconic Royal Oak Music Theatre. Home to vibrant art galleries, the Detroit Zoo, the Detroit Institute of Arts, and the charming Royal Oak Farmers Market, this city offers a perfect balance of work and play. Consider Royal Oak for your next career move and embrace a dynamic lifestyle in a welcoming community!
You will find a wide range of opportunities with our partners across the US in a diverse set of industries and sectors. We also have a strong network of European based organizations, especially Italian organizations, that operate in the US looking for top professionals to join their team.