Required Quality Engineer
Job Description Summary
Responsible for supporting and coordinating Design Control activities across the product lifecycle. Ensures new product development and design changes follow applicable Design Control processes, including design planning, requirements and traceability, design verification and validation, formal design reviews, design transfer, risk management, design change, and Design History File requirements. Partners with cross-functional teams to identify gaps, resolve issues, maintain compliance, and drive effective execution of product development activities.
Job Description
Roles and Responsibilities:
Engineering Procure Construct tendering and project execution phases. Verify contractual and regulatory requirements are fulfilled and have maximized customer satisfaction and profitability. Establish and execute project quality plan, witness-points, quality records for compliance with contract. Ensure customer quality requirement, Feedback of Experience (FOE)/Lessons Learned are taken into account in the tender proposal to avoid deviation and to continually improve execution processes.
Utilizes in-depth knowledge of a discipline and analytical thinking to execute policy/strategy. Basic knowledge of related job disciplines.
Acts as a resource for colleagues with less experience. May lead local improvement projects and be part of global projects/initiatives. Explains information; developing skills to bring team members to consensus around topics within field. Conveys performance expectations and may handle sensitive issues.
Jobs at this level function with some autonomy but are subject to functional practices and precedents or are covered by well-defined policies or review of end results. The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).
Uses some judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own team to arrive at decisions.
Requirements: Required Qualifications:
This role requires advanced experience in the Quality & QA Engineering. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience).
3-5 years working experience in Quality Engineering in Medical Device company.
Desired Characteristics:
Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.
Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment.
Ability to communicate globally using English.
Ability to multi-task & handle tasks with competing priorities effectively
Excellent interpersonal relationship - team player and team -oriented.
Demonstrated collaboration, negotiation & conflict resolution skills.
Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.
This position is open to all candidates.