The Quality Engineer I provides Quality Engineering support to Manufacturing, Engineering, QC/QA and Process Development teams to ensure that products are manufactured with a high level of quality, while being in compliance with regulations governing medical device manufacturing.
ESSENTIAL JOB FUNCTIONS:
Project and process planning and execution skills to ensure regulatory requirements (e.g. design control) and process/product goals (e.g. process capability) are met
Work with multiple project schedules and manage competing priorities
Identify specification needs/requirements & assist with the creation of specifications
Support design transfer activities focused in development of gage design, inspection processes, GRR, capability studies and process validation
Facilitate Design Review activities of new products and work closely with product design teams to ensure quality considerations during all stages of product development
May direct the work of Quality Technicians
Provide guidance and help solve significant or chronic process or product problems. Discuss customer problems with Marketing and Sales as needed
Generate, analyze, and present reports on quality related Key Performance Indicators (KPI) such as line yields, final release, supplier performance and customer experiences to internal product improvement teams
Become proficient with SAP applications that track internal and external failures
Support Quality Systems such as delivery holds, internal and external audits, CAPA and investigations
Bachelor’s degree in an Engineering or Science discipline or equivalent technical background, with emphasis in Quality or related fields preferred.
Must have 1 to 3 years of experience with preferred experience working within the medical device industry and have the understanding of, and ability to interpret, regulations and guidelines governing medical devices including knowledge of ISO 13485 and 21 CFR 820- Product Management experience is a plus
Data analysis & critical thinking skills -Ability to adapt & learn quickly -Good written & verbal communication; responsiveness -Ability to work well within a team and relate to all levels within the company
Conducts investigations and trains personnel on methods and statistical analysis tools. Experienced in the use of quality tools such as Failure Modes Effects Analysis (FMEA), Fault Tree Analysis (FTA), Fish Bone Diagram, Risk Analysis, or other appropriate methods to define and manage risk or identify root cause of failure. Understanding and experience in applying quality assurance and control tools (statistical analysis, DOE, gauge R&R and SPC).
Strong working knowledge of process development and validation methodologies (IQ,OQ,PQ).
Experience interacting directly with suppliers, Manufacturing, and Manufacturing support organizations.
Understanding and experience in applying quality engineering concepts such as process capability analysis, risk assessment, PFMEA and DFMEA.
GD&T knowledge/experience (preferred)
Electronics background (preferred)
Bioventus - 2 years ago