Design/Manufacturing Assurance

Guide companies to follow the industry specific and international standards and guidelines during design, development and manufacture of products/services. Perform necessary assurance and gate checks including verification and validation to produce safe and effective products.

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Regulatory Submission

Guide companies to design and develop products adhering and fulfilling the regional and international regulatory requirements. Prepare documents necessary for regulatory submission including design and manufacturing records, labelling, registration and more.

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Audit

Prepare companies to fulfill and adhere to quality, regulatory and customer requirements. Support companies to prepare for regulatory authority, notified body or customer audits. Conduct internal and supplier audits.

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Quality and Risk Management

Implementation of effective quality management system per standard and company’s policy and procedure. Integrating risk-based thinking in to products and processes. Perform risk management activities to develop and manufacture safe and effective products.

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Improvement

Perform assessment to uncover the deficiencies in the system and root causes. Support in implementing efficient and effective corrective and preventive actions. Cultivate continuous improvement culture by implementing industry’s best methodologies and techniques like Lean, Six-Sigma, CMMI and more.

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Statistics and Data Analysis

Apply scientific and data focused methods to resolve complex and challenging problems and to improve efficiency. Support to adapt a suitable statistical and data analysis methods in design, development and manufacturing processes.

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Training and Coaching

Provide training on various quality, regulatory and improvement standards, guidelines and methodologies. Training and preparation to obtain various skills/certifications. Provide a necessary support to enable change is smoother and to make part of organization’s culture.

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Location: Canada

  • Phone:
  • Email: info@qr-konnect.com

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