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Quality Assurance Manager

We are looking for an experienced Quality Assurance Manager to join our team to build and own our quality space, a key role in the company. Your primary responsibility will be to develop and deploy a complete QMS, support quality-by-design and manufacturing, support customer services as quality lead, and manage supplier quality assurance. You will lead by example and have a good balance of hands-on work. You will have a global footprint, supporting customers and suppliers from around the world and at the same time work on high-impact R&D projects addressing challenges and real-life implementation of new technologies.

Who you are

  • Analytical skills – need to be able to spot problems quickly and find the underlying causes so changes can be made.
  • Critical thinking – once problems are identified, solutions and improvements must be found. This might involve thinking about a process, procedure or problem in a completely new way.
  • Attention to detail – as the people responsible for the creation and implementation of quality systems, as well as the people who notice and report on problems, every detail must be noticed and acted upon when necessary.
  • Numerical skills – statistical analysis can be a big part of a quality engineering role.
  • Communications skills – strong written and verbal communication skills are key. Must be able to relay potentially complex ideas to a wide range of audiences.
  • Conflict resolution skills – A well-defined sense of diplomacy, including solid negotiation, conflict resolution, and people management skills will be key.
  • Leadership skills – You will need vision and ability to drive and lead stakeholders and team members.

 

What you’ll do

Overall 

  • Own, build and lead Sunwell Technologies quality space based on your experience and industry best practice.
  • Lead by example and have a good balance of hands-on work.
  • In collaboration with all departments, take ownership of the Quality Management System; develop and execute company quality standards and quality assurance program. Ensure that the performance of the QMS is reviewed at planned intervals to ensure its continuing suitability, adequacy and effectiveness.
  • Create, collect and analyze Quality Key Performance Indicators (KPI) to identify actionable trends.
  • Build towards expanding and manage the quality team.

Quality Assurance          

  • Drive and monitor all quality activities to ensure existing regulatory adherence at the company.
  • Ensure that records are established and maintained to provide evidence that the QMS is being followed and that there is a system in place for the identification, storage, protection, retrieval, retention time and disposition of such records.
  • Ensure that all staff are inducted into the requirements of the QMS related to their own roles and responsibilities. Prepare and maintain training modules for quality systems and conduct training as needed.
  • Support development and upkeep of work instructions, standard operating procedures, setup instructions, and other related process documentation for shop floor use.
  • Lead the development and implementation of key process documents, including: FMEA, Control Plan, Standard Work, Product Standards
  • Performs continuous improvement activities using lean tools for cost reduction, quality improvement, improved efficiency, and improved material flow.
  • Lead teams to identify and resolve quality issues, using tools such as Failure Analysis, Root Cause Analysis including Fishbone, 5Why and Is/Is Not

Quality by Design           

  • Support engineering team during new designs and modifications in during such stages as risk analysis, design review, verification and validation.
  • Review and approve research design/process design/manufacturing documents, such as Design Verification/Validation Plans/Protocols, Risk Management, Design Inputs and Design Reviews
  • Work with product design/development teams and manufacturing operations to translate design requirements into manufacturing requirements to increase manufacturability, reduce scrap and improve operational efficiencies.

Customer Service Quality           

  • Support service team in responding to customer issues, investigate customer non-conformances, and support the team to implement corrective action.
  • Communicates with customer and supplier in regards to quality issues as requested.
  • Act as liaison with customer auditors and assume responsibility for ensuring corrective actions with customer specifications.
  • Establishes action plans and drive priority incident investigations and create executive level presentations for management reporting.
  • Conduct technical engineering investigations of customer reported incidents to identify the need for design or manufacturing countermeasure action.
  • Be willing and able to travel to customer sites as necessary.
  • Conduct meetings and communication with the responsible departments to ensure countermeasure development is completed in a timely manner.

Supplier Quality Assurance        

  • Establish and maintain a QA program for monitoring supplier quality, including audits, controls, and other qualifiers.
  • Responsible for supplier development and/or sourcing. Be willing and able to travel to supplier sites to perform assessments as necessary.
  • Eliminate supplier quality and engineering ensuring robust countermeasures to SPPS.
  • Understanding the requirements, work with Engineering and the Buyer to assess the technical capability and roadmap of the supplier.
  • Manage team of contracted 3rd party and supplier site embedded quality auditors / inspectors as necessary.
  • Align product verification/test between suppliers and the internal production facility.
  • Analyze Supplier Initiated Non Conformances & Non Conformances Reports to ensure that trends are identified and resolved. Ensures timely and effective closure of Supplier Corrective Action Requests.
  • Ensure purchasing and commercial contracts account for quality requirements.
  • Responsible for defining material handling requirements from the supply chain to storage at Sunwell or Client sites.
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