The Quality Engineer II provides Quality Engineering support to Manufacturing, Engineering, Quality Control /Quality Assurance, 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.
Key Responsibilities:
- Utilizes project/process planning and execution skills to ensure regulatory requirements (e.g. design control) and process/product goals (e.g. process capability) are met
- Works with multiple project schedules and manage competing priorities
- Identifies specification needs/requirements & assist with the creation of specifications
- Supports design transfer activities focused in development of gage design, inspection processes, GRR, capability studies and process validation
- Facilitates Design Review activities of new products and work closely with product design teams to ensure quality considerations during all stages of product development
- Provides guidance and helps solve significant or chronic process or product problems. Discusses customer problems with Marketing and Sales as needed
- Generates, analyzes, and presents reports on quality related Key Performance Indicators (KPI) such as line yields, final release, supplier performance and customer experiences to internal product improvement teams
- Analyzes internal and external failures utilizing knowledge of SAP applications
- Supports Quality Systems such as delivery holds, internal/external audits, CAPA and investigations
- Holds oneself and others accountable to conduct business in a manner compliant with Bioventus' Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role.
- Other duties as assigned
Education and Experience (Knowledge, Skills & Abilities)
- Bachelor's degree in an Engineering discipline or equivalent technical discipline, with emphasis in Quality Engineering preferred.
- Minimum 2 years' experience (preferably within the medical device industry and having the understanding of, and ability to interpret, regulations and guidelines governing medical devices including Knowledgeable of ISO 13485 and 21 CFR 820)
- Experience using, understanding and interpreting regulations/guidelines governing supplier quality and development of electro-medical equipment and/or software including knowledge of the IEC 60601-1 family of standards, ISO 62304, 62133, 14971 and EMC requirements.
- 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
- 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 and electronics knowledge/experience (preferred)
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