Staff Engineer, Quality - 12 Month Fixed Term Contract
Provide quality leadership and direction in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance to regulation and standards.
What You'll Do:
* Work closely with operations and the business functions to ensure quality performance of product and processes.
* Mentor, provide oversight and approval of NC & CAPA, act as a high-level expert in problem solving and root causing activities.
* Initiate and lead the development and improvement of the manufacturing processes for existing and new products.
* Oversee and lead investigations during concession management.
* Review and approve change management activities, challenge change effectiveness and drive strong review.
* Interpret KPI trends, take action as necessary, driving a continuous improvement process.
* Advocate for Human Factor practices, proficient in the science of Human Factor identification and mitigation.
* Serve as a subject matter expert in risk management practices and tools, with high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.
* Provide technical direction in optimization of inspection methods and sampling.
* Exhibit high proficiency in statistical methods and application.
* Participate in and may lead internal & external audits with regulatory representatives, providing effective narrative and description of topics 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.
* Initiate, manage, and support ship, product holds, and potential product escapes.
* Coach and mentor the quality team and other business functions in quality topics and activities, at an expert level.
* Deputize proficiently for management in temporary absence, periodic review boards, business meetings, etc. on a regular basis.
What You'll Need:
* Bachelor's degree in Science, Engineering or equivalent/related subject and 4 years of work experience in a quality discipline, or
* Master's of Science, Engineering or related subject with 2 years of experience.
* Previous experience in a regulated environment required.
* CQE or equivalent coursework/experience desirable.
* Proficient understanding of Med Device manufacturing processes required.
* Proficient in ISO 13485, GDP, GMP.
* Lean Six Sigma training is a distinct advantage.
* Excellent communication skills and attention to detail.
* Good understanding of engineering and quality practices & methods.
* High level of PC skills; must be proficient with Microsoft Word, Microsoft Excel, and PowerPoint packages.
* Exhibit strong leadership and mentoring behaviors.
* Self-starter with demonstrated efficient work methods, analytical & problem-solving skills, and ability to handle multiple tasks in a fast-paced environment.
* Willingness to work as part of a multi-site team, with some travel required.
* High level of 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.
* Build strong relationships by fostering open communications, respect, and trust. Strong team player with a customer service/stakeholder-focused approach.
* Diplomatic, tactful, and leverages excellent interpersonal skills to help achieve outcomes.
* Present as a change agent and adopt 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.
Travel Percentage: None
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