Quality Engineer

As a Quality Engineer, you will play a pivotal role in ensuring the highest standards of quality across our operations. You will be responsible for planning and directing assigned operational and improvement activities, along with driving continuous improvement initiatives. Your leadership will be crucial in maintaining product quality and enhancing business acumen and functional skills within the organization.

• This is a higher-level role responsible for improving systems and influencing business decisions.
• You improve and influence how the system works.
• Reviewing and updating the QMS to keep current with operational needs.
• Maintaining records, e.g. lot history, training, and maintenance records.
• Collaborate with various groups to manage the inspection processes of in-process and finished goods and components.
• Ensure proper implementation of inspection procedures and standards to maintain product integrity and compliance.
• Perform in-process and final inspections as required.
• Ensure that the product quality status is consistently maintained throughout the production process.
• Ensure products in both intermediate and final states, meet all quality standards and specifications.
• Ensure that all staff members are adequately trained to perform their assigned tasks effectively.
• Develop and implement training programs to enhance the skills and knowledge of the team.
• Identify opportunities for process improvements and lead the implementation of strategic initiatives and changes to enhance efficiency, productivity, and quality.
• Utilize appropriate approaches to monitor performance and drive continuous improvement initiatives.
• Provide guidance for inspection related processes in new product transfers from NPD to production.
• Perform other incidental duties as required to support the overall objectives of the organization.
• Monitor and maintain Supplier status, agreements, and complaints.
• Review and investigate non-conformities and
• Reviewing documentation and ensuring they meet GMP and current practices
• Other duties as required by management

• Bachelor’s degree or a minimum of 5 years in Manufacturing, Quality, and/or Product Development Engineering.
• Experience working within a highly regulated industry
• Excellent communication and interpersonal relationship skills; possessing strong collaboration skills in partnering with cross functional stakeholders to achieve objectives, as well as mediating differences to achieve consensus.
• Strong analytical skills, strategic thinking capability and sound business judgement

What else we look for (Preferred Qualifications)

• Medical device, pharma, or biotech industry experience preferred
• Lean/Six Sigma experience
• Experience with quality inspections and quality engineering/assurance techniques, procedures, instruments, equipment, theories, principles, and concepts and general business operations.