Quality Engineer II
Bioventus · Memphis, TN
- Level
- Engineer
- Team
- Quality
- Degree
- Preferred
- Experience asked
- 2+ years
- Industry
- Medical devices
- Posted
- 30+ days ago
The role in 30 seconds
An engineer-level quality role at Bioventus (medical devices) in Memphis, TN. 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.
- They ask for
- 2+ years · degree preferred
- Tools it names
- SPC, FMEA, MSA / Gage R&R, CAPA, GD&T, DOE
Read from the posting. The full description is below.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
Your game plan for this job
Most people just hit Apply. Do these first and you show up with someone on the inside.
- 1
Find 2–3 people on the Quality team at this site
Engineers who joined in the last year or two reply most.
- 2
Send a short, curious note
Ask about the work, not for a referral. We write it for you.
- 3
Have a 15-minute chat
Good questions for this role:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- How did you land the job? What stood out in your interviews?
- 4
Apply, ideally with a referral
Ask if they'd refer you or introduce you to the hiring manager. Send your résumé link and tell them the day you apply.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
About the role
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 met
2. Works with multiple project schedules and manage competing priorities
3. Identifies specification needs/requirements & assist with the creation of specifications
4. Supports design transfer activities focused in development of gage design, inspection processes, GRR, capability studies and process validation
5. Facilitates Design Review activities of new products and work closely with product design teams to ensure quality considerations during all stages of product development
6. Provides guidance and helps solve significant or chronic process or product problems. Discusses customer problems with Marketing and Sales as needed
7. 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
8. Analyzes internal and external failures utilizing knowledge of SAP applications
9. Supports Quality Systems such as delivery holds, internal/external audits, CAPA and investigations
10. 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.
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)
Are you the top talent we are looking for?
Apply now! Hit the “Apply” button to send us your resume and cover letter.
Show full description ↓Show less ↑
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.