We are looking to speak with an experienced Quality Project Engineer to join a Medical Device client of ours. This role will involve regular travel to sister sites, nationally and internatiionally. This is a 12 month contract, fully onsite.
Essential Qualifications:
- Solid grasp of quality methodologies, including risk management, CAPA (Corrective and Preventative Action), audits, and statistical analysis.
- Proven excellence in communication, project coordination, and the ability to influence stakeholders without formal authority.
- Skilled at juggling multiple assignments concurrently.
- Competent in representing the Quality function within various project teams.
- Outstanding interpersonal abilities, along with strong written, verbal, and negotiation skills.
- Innovative and analytical thinker, adept at approaching challenges from fresh perspectives.
- Highly developed problem-solving and analytical competencies.
- History of successfully steering projects to completion in a matrix organization.
- Ability to work independently as well as within cross-functional teams.
- Proficient with computer systems and software.
- Willingness and flexibility to travel as required.
Primary Responsibilities:
- Partner with operations and business units to ensure superior quality in both products and processes.
- Collaborate with Divisional QA, cross-functional groups, and suppliers to address and resolve key quality concerns.
- Manage and drive the closure of both internal and supplier-related nonconformance issues; lead or support CAPAs by overseeing root cause investigations, implementing corrective actions, and ensuring timely resolution.
- Oversee the disposition of non-conforming products within the MRB framework, including issuing nonconformance reports when needed.
- Liaise with suppliers regarding nonconformances, escalating corrective action requests as necessary.
- Contribute to the ongoing development and enhancement of manufacturing processes for existing products.
- Conduct thorough evaluations of change management proposals from internal teams and suppliers to ensure quality standards are maintained.
- Assist in the development and revision of procedures and work instructions.
- Monitor key performance indicators (KPIs) related to product and process quality, analyze trends, and initiate appropriate corrective measures.
- Support investigations and analyses related to manufacturing complaints and field actions.
- Advocate for Human Factor principles by identifying, reducing, and mitigating human error risks.
- Work closely with relevant stakeholders to pursue opportunities for supplier part certification.
- Build a strong understanding of risk management principles and apply them effectively within manufacturing operations.
Educational Background and Experience:
- A Bachelor's degree in Engineering (BSc/B.Eng.) or a related field is preferred, or equivalent professional experience.
