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Quality Engineer for Post Market in Medical Device Industry
3 months ago
Come to work for a world renowned Medical Device company This position is contract to hire and has some flex for hybrid.
We are seeking a dynamic individual who has an Engineering degree and some experience within a quality department doing post market quality work that supports the quality complaint and investigation teams for the clients products.
Key focus is on understanding and developing product and process specific improvements to increase rate of actionable outcomes of product investigations and improved use of Engineering Essentials and Problem-Solving Analytics to improve product performance in sustaining and future product lines.
Will identify, coordinate, and execute project priorities based on business and department objectives and at times at the Global BSC level.
Responsible for identifying and implementing continuous improvements to improve product performance and complaint processes. This role provides significant visibility across site and divisional leadership.Key Responsibilities
- Analyzing customer complaints, events, and other post market surveillance data by examining the data for patterns and trends and investigating when necessary.
- Conducting product signal escalation analysis, investigation, and quality system documentation to identify performance improvement opportunities. May include NCEP & CAPA ownership.
- Mentoring product investigators by providing technical guidance in identifying and resolving quality issues using engineering essentials and other related problem-solving tools and techniques. Grow team utilization of investigative equipment (X-Ray, FTIR, SEM, etc.)
- Partnering with cross-functional teams to ensure the development and execution of streamlined, robust solutions to CIS processes are effectively implemented while still meeting organizational and regulatory requirements.
- Communicates product performance by formal presentations to management committees and design teams, supporting published product performance reports and supporting customer requests for performance information either directly or through the sales organization.
- Focusing on continuous improvement by championing and fostering the execution of projects within the local and Global Post Market organizations.
Recent grad with some coop/intern experience would be excellent. or 1 year of related experience Preferred
Qualifications * Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards * Experience in Medical Device industry or a Quality organization * Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook * Ability to collaborate and influence across multiple, cross-functional teams * Knowledge of analytical techniques, problem solving, continuous improvement programs, and statistical analysis * Self-starter with the ability to identify improvement opportunities
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About Advantage Technical
With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today.
These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America.
Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visitAdvantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors.
We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. Advantage Technical is an E-Verify employer.This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.
All employees are directed to familiarize themselves with this policy and to act in accordance with it.All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.
Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors.
This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.
