Work Flexibility: Hybrid
Provide quality leadership and technical guidance on preventative quality within operations and other business functions at local and global level, advocating and leading 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.
Staff Quality Engineer
Place of work: Skawina
Ref no: R523772
Role description
Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:
- Work closely with business functions assess, provide oversight and direction on quality performance of product and processes.
- Mentors, provides oversight and approval of NC & CAPA, activist and high level expert in problem solving and root causing activities.
- Coach and mentor the quality team and others business functions in quality topics and activities, with several topics at expert level.
- Leads / Manages quality initiatives / projects at local & global level.
- Recognized process owner in areas of expertise. Expertise across multiple areas from the following, problem solving, risk, concession & change management, lean, six sigma, CAPA, statistics, validation, inspection processes & sampling etc.
- Input into local, global & corporate processes, a representative on review & discussion boards and teams for expert & valued input.
- Provides input / assessment and justification at expert level during concession / change management and quality issues. Review and approval of same driving strong review.
- Interpret KPI trends, take action as necessary, driving a continuous improvement process.
- Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
- 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. Oversight/deputize for audit management, logistics and preparation as required.
- Aids in the development of validation strategies, certified in multiple disciplines of validation to approval level.
- Support/ Leads manufacturing transfers to other plants/facilities, leading quality activities.
- Responsible for initiation, management and support of ship, product Holds, potential product escapes.
- Steps in proficiently for management in temporary absence, periodic review boards, business meetings etc on a regular basis.
Education and experience
- Masters of Science, Engineering or related subject with 6 years of experience in a quality discipline.
- Previous experience in a regulated environment required.
- Proficient in understanding of Med Device manufacturing processes, ISO 13485, GMP.
- Lean / Six Sigma training a distinct advantage.
- Excellent communication skills and attention to detail.
- Have a good understanding of engineering and quality practices & methods.
- High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
- Exhibits 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.
- Must be willing to work as part of a multi-site team, with some travel required.
- High level knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
- Highly developed problem solving and strong analytical skills.
- Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach.
- Is diplomatic, tactful and leverages 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 fun.
Travel Percentage: 10%
