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Senior Quality Engineer - New Product Development

Find what drives you on a team with a more than 70-year history of discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers protect people. Our products serve a wide range of markets, so if your interests lie along the spectrum of Life Sciences to Industrial, you’ll find a rewarding role here. For the exponentially curious, Pall is a place you can thrive and amplify your impact on the world.

Pall is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

You will provide quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, support business and customer needs, and align with government regulations, industry and company standards. You may be also responsible for supplier selection & auditing, material qualification, material inspection and test, performance monitoring and supplier development. You may manage process and product non-conformities in line with company procedures and conduct quality assurance tests to ensure product specifications are met. Reviewing, investigate, resolve and reporting on quality discrepancies are part of your responsibilities as well as develop, maintain, supervise, and auditing quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards and report on customer complains. You will be acquiring the vital quality system certifications and licenses (e.g. ISO, CE) to support market release of new product development, when needed and lead audit and inspection preparation, resolution of findings. You will have to interact frequently with other functional areas and operating entities within the Group.

Are you willing to take part in new product introduction projects lead by our R&D department ? As part of an impressive team, are you an expert in providing quality input throughout the process of developing new products from early start until transfer to routine production working alongside with several other functions? Then this could be your next career step !

You will also have the opportunity of :

  • Brainstorm and support project team on how new products can serve customers better from all points of view (quality manufacturability, cost, environmental, …)
  • Support/lead discussions and work closely with other departments (Research & Development, Product Engineering and Manufacturing) to implement/maintain, Process flow charts, Process Control Plans, Process FMEA, validations and the VPM while supporting and guiding the project teams through quality requirements and documentation, optimizing the company's products and relationships with our customers including technical presentations to customers
  • Support transfer from NPD to high volume manufacturing and develop quality control plans
  • Issuing, reviewing and approving NPD related validation documents
  • Setting up gamma irradiation process and product sterility claims for new products
  • Bundle all required information to set up regulatory dossiers when needed during new product introduction
  • Support supplier qualification process for new suppliers related to product development
  • Help translate current QMS elements into requirements for new products to meet ISO 9001 requirements
  • Perform Internal Audits or quality inspections per the annual audit schedule, prepare report, follow-up and verification of completion of actions initiated from audit(s). Maintain and supervise change control and customer notification documents as well as Quality critical metrics
  • Support responses to customer questionnaires, certification requests and surveys; prepare and maintain/update standard responses/data for use by Customer Service, customer audits and be the quality contact for customer and supplier questions regarding sterility, validation and deviation.
  • Implement continuous improvement practices, including appropriate kaizen events on relevant Quality processes. Support Shin Kaizen events and use Lean manufacturing principles, as and when required.
  • We are looking for an open, out-going and collaborative person with natural self-confidence and power. You will be working in a team but it’s a huge plus that you are independent, self-motivating and committed since you will drive your own activities. Some of the words to describe you should be creative, structured and analytical with a helicopter view and a positive and constructive way of thinking. Overall a person with a focus on developing and continuous improvements.

    Main Requirements:

  • Degree in applicable field or equivalent by experience in Quality in a similar (GMP)/ISO regulated BU/Industry
  • 5 + years of relevant quality experience which 3 in an equivalent industry
  •  Proficient in English. Dutch is highly appreciated.
  • Strong quality assurance principles and practices knowledge and experience within industry and international regulations and standards
  • Familiar with ISO9001. Knowledge of ISO 15378/ ISO13485 is recommended while ISO11137, ISO14644 and ISO14698 are would be much appreciated
  • Validation/qualification experience and project management are a must
  • Proficiency in Excel (statistical), ERP system and LIMS are a plus
  • Six Sigma
  • Ability to travel 5-15% (domestic and international)
  • When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful tools and the stability of a tested organization.

    At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

    If you’ve ever wondered what’s within you, there’s no better time to find out.

    Senior Quality Engineer - New Product Development

    Pall, Hoegaarden
    Categories: 
    Quality Engineer
    Career level: 
    Senior