Quality Engineer II

Bioventus; Memphis (TN); On-site; USD 70,000 - 100,000; Full time

Job summary

Bioventus is seeking a Quality Engineer II to support Manufacturing, Engineering, and QA in delivering high-quality medical devices. The role focuses on design controls, process validation, and statistical analysis to improve product quality and compliance.

You will work with cross-functional teams to ensure regulatory alignment and drive sustainable quality improvements across development, transfer, and production stages.

Qualifications

• Bachelor’s degree in an Engineering discipline with emphasis in quality engineering preferred.
• 2+ years’ experience in medical device quality engineering with understanding of regulations including ISO 13485 and 21 CFR 820.
• Experience interpreting regulations for supplier quality and development of electro-medical equipment/software including IEC 60601-1 family, ISO 62304, 62133, 14971 and EMC requirements.
• Data analysis and critical thinking; proficient in statistical methods, DOE, gauge R&R, SPC.
• Familiar with quality tools and process development/validation (IQ/OQ/PQ).
• Interaction with suppliers, manufacturing, and support organizations.

Responsibilities

• Supports regulatory requirements (design control) and process/product goals.
• Manages multiple schedules and competing priorities.
• Helps create specifications and transfer activities (gage design, inspection, GRR, capability studies).
• Facilitates design reviews ensuring quality considerations throughout product development.
• Guides on significant process/product problems and discusses customer issues with Marketing/Sales as needed.
• Analyzes KPI data (line yields, final release, supplier performance, customer experience) for improvements.
• Utilizes SAP for failure analysis and supports quality systems (audits, CAPA, investigations).
• Adheres to Bioventus Code of Compliance and internal controls.

Skills

Quality engineering

Regulatory knowledge

Data analysis

DOE

Gage R&R

Team work

Communication

Education

Bachelor's degree in Engineering

Tools

SAP

Job description

Are you ready to work for a more active world?At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.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:1. Utilizes project/process planning and execution skills to ensure regulatory requirements (e.g. design control) and process/product goals (e.g. process capability) are met2. Works with multiple project schedules and manage competing priorities3. Identifies specification needs/requirements & assist with the creation of specifications4. Supports design transfer activities focused in development of gage design, inspection processes, GRR, capability studies and process validation5. Facilitates Design Review activities of new products and work closely with product design teams to ensure quality considerations during all stages of product development6. Provides guidance and helps solve significant or chronic process or product problems. Discusses customer problems with Marketing and Sales as needed7. 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 teams8. Analyzes internal and external failures utilizing knowledge of SAP applications9. Supports Quality Systems such as delivery holds, internal/external audits, CAPA and investigations10. 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.11. Other duties as assignedEducation 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) Are you the top talent we are looking for?Apply now! Hit the “Apply” button to send us your resume and cover letter.Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms of diversity and take pride in working with top talent from every walk of life. In the spirit of inclusivity, qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion or sexual orientation. All individuals, regardless of personal characteristics, are encouraged to apply.