Document Control – Medical Device
Houston , Texas
Document Control, Medical Device – Houston, TX
If culture and mentorship are your priorities – you’ve found your match. This pioneer company in Medical Device is looking to support and promote a talented Document Control specialist who will support QMS and ISO regulations. The ideal professional will have experience working in an ISO 13485 regulations and is familiar with arena PLM system, as well as eagerness to join and contribute to a tight knit, mutually supportive community of skilled experts.
What you’ll do
- Develops and implements quality management system (QMS) documentation related to change control activities.
- Administers the Arena PLM electronic documentation system including identification scheme, user accounts, electronic signature maintenance, as well as system validation and test activities.
- Delivers training to all levels of organization on the document control process and electronic document control systems including the new hire orientation, Arena PLM, and QMS training.
- Acts as a Subject Matter Expert (SME) for the document control function during internal and external audits including being in the front room with the auditor.
Who you are
- Degree in Sciences (or Degree and 5+ years relevant work experience).
- 3+ years’ experience with class II/III medical device in Quality.
- Previous Document Control experience.
- Working knowledge of ISO 13485, 21 CFR Part 820 QSR, and Medical Device Regulation (euMDR).
- PLM/ERP integration experience.
Why work here
- Supportive leadership & team: you’ll work with an intelligent, productive, appreciated and supportive team who enjoy and has a reputation for mentoring and developing others with a drive for success.
- Competitive package: this role offers base, bonus, equity, and benefits.
- High-growth environment: this company is rapidly expanding and is looking for people who can grow with them.
Please email your resume to email@example.com if you’d like to work alongside some of the finest professionals in the Life Sciences Industry!
Note: We actively support and promote people of various backgrounds, from race, religion, gender to geographical area, university, lifestyle, and personality type. Proven Recruiting is minority-owned, majority women, and is a strong advocate for diversity and inclusion in the broader community. Apply today!