Staff Engineer, Quality - 12 Month Fixed Term Contract
As a Staff Engineer in Quality, you will provide quality leadership and direction in quality assurance, control, and preventative activities within operations and other business functions. Your focus will be on preventative measures and continuous improvement of products and processes.
You will advocate and lead the execution of initiatives & projects to enhance quality performance within the business.
Mentoring and providing technical direction across multiple areas of expertise are also key responsibilities.
Ensuring compliance to regulation and standards is essential in this role.
Key Responsibilities:
* Work closely with operations and the business functions to ensure quality performance of product and processes.
* Mentor, provide oversight, and approval of NC & CAPA, activate, and high-level expert in problem-solving and root-causing activities.
* Initiate and lead the development and improvement of manufacturing processes for existing and new products.
* Oversight and lead investigations during concession management.
* Review and approval of change management activities, challenge change effectiveness, and drive strong reviews.
* Interpret KPI trends, take action as necessary, driving a continuous improvement process.
* Advocate Human Factor practices, proficient in the science of Human Factor identification and mitigation.
* Subject matter expert in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.
* Proficient in optimization of inspection methods and sampling, with high proficiency in statistical methods and application.
* Participate in and may lead internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. Manage audit logistics and preparation.
* Aid in the development of validation strategies, certified in 1 or more areas of validation including approval of validation.
* Support manufacturing transfers to other plants/facilities, leading quality activities.
* Responsible for initiation, management, and support of ship, product holds, potential product escapes.
* Cross-functional coaching and mentoring of the quality team and others in quality topics and activities, with several topics at an expert level.
* Deputise proficiently for management in temporary absence, periodic review boards, business meetings, etc., on a regular basis.
Requirements:
* Bachelor's degree in Science, Engineering, or equivalent/related subject and 4 years of work experience in a quality discipline, or Master's degree in Science, Engineering, or related subject with 2 years of experience.
* Previous experience in a regulated environment is required.
* CQE or equivalent coursework/experience is desirable.
* Proficient understanding of Med Device manufacturing processes is required.
* Proficient in ISO 13485, GDP, GMP.
* Lean Six Sigma training is a distinct advantage.
* Excellent communication skills and attention to detail are essential.
* Good understanding of engineering and quality practices & methods is required.
* High level of PC skills, with proficiency in Microsoft Word, Microsoft Excel, and PowerPoint packages.
* Strong leadership and mentoring behaviours are expected.
* Self-starter with demonstrated efficient work methods, analytical, and problem-solving skills, and ability to handle multiple tasks in a fast-paced environment.
* Will to work as part of a multi-site team, with some travel required.
* High-level knowledge/experience of Risk Based and statistical techniques, particularly process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
* Highly developed problem-solving and strong analytical skills.
* Foster open communications, respect, and trust, building strong relationships.
* Diplomatic, tactful, and leverage excellent interpersonal keys to help achieve outcomes.
* Presents as a change agent and adopts a continuous improvement orientation to the role.
* Excellent English (both oral and written).
* Ability to be the voice of Quality when dealing cross-functionally, taking the lead in discussions/meetings to ensure the correct outcome.