Sr Quality Engineer

Bioventus•Memphis, TN

15d

About The Position

The Sr Quality Engineer provides quality engineering expertise to manufacturing, engineering, quality control/assurance and process/product development teams to ensure our products are designed and manufactured to a high level of quality, and compliant with medical device regulations.

Requirements

Bachelor’s degree (Masters preferred), in an Engineering discipline or equivalent technical background, with emphasis or experience in electronics, circuits and/or software. Electrical Engineering or related fields preferred.
Minimum 5 years (with Bachelor’s) or 4 years (with Master’s) of experience within the medical device industry with a comprehensive understanding of, and ability to interpret regulations and guidelines governing medical devices including ISO 13485 and 21 CFR 820 and EU MDD/MDR.
Strong working knowledge of process and product 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 management, PFMEA and DFMEA.
Previous Quality Engineering or Product Development experience and GD&T and electronics knowledge/experience is required.

Responsibilities

Ensure medical device regulatory requirements (21 CFR 820, EU MDD/MDR, ISO 13485:2016 and IEC 60601 series) related to design control and process/product goals (e.g., process capability, yield, reliability) are met utilizing project planning and execution skills.
Identify and manage needs/requirements and assist with the creation and/or modification of product and process specifications.
Lead design transfer activities focused in development of gage design, inspection processes, GR&R, capability studies and process validation.
Actively participate in Design Review activities of new products and work closely with product design teams to manage quality considerations during all PLM stages of product development.
Provide guidance and work to solve significant or chronic process or product problems. Discuss customer concerns or complaints with Marketing and Sales as needed.
Generate, analyze, and present reports on quality related Key Performance Indicators (KPIs) such as line yields, final release, supplier performance and customer experiences to internal product improvement teams.
Support Quality Systems such as delivery holds, internal and external audits, CAPA and investigations.
Update and revise procedures to consistently meet regulatory requirements such as EU MDR, IEC 60601 series, ISO 13485:2016, 21 CFR 820, etc.
Analyze and act on process trend data including leading investigations, root cause analysis and assist with corrective actions.
Hold 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.