More jobs:
Sr. Quality Technician
Job in
Maple Grove, Hennepin County, Minnesota, 55311, USA
Listed on 2025-12-22
Listing for:
Cypress HCM
Full Time
position Listed on 2025-12-22
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Base pay range
$80,000.00/yr - $95,000.00/yr
Manufacturing Quality Senior Technician / EngineerWe’re looking for a Manufacturing Quality Senior Technician / Engineer to support process development and quality inspection for tissue processing used in structural heart medical devices
. This is a hands‑on role working closely with R&D, Operations, and Regulatory in a fast‑paced, innovative environment.
- Execute lab‑based process development runs for bovine pericardium tissue processing
- Implement quality controls to ensure tissue performance, biocompatibility, and repeatability
- Establish manufacturing procedures, inspection criteria, and in‑process controls
- Partner with external testing vendors and manage test schedules and sample logistics
- Review technical documentation (protocols, reports, risk files) supporting regulatory submissions
- Collaborate cross‑functionally with R&D, Operations, and Regulatory Affairs
- Drive continuous improvement across quality systems and process development
- 3–5 years of experience in Quality Assurance
, preferably within structural heart technologies - Hands‑on experience implementing quality inspections for tissue processing
- Strong understanding of GMP requirements for sterile medical device manufacturing
- Familiarity with FDA QSR, ISO 13485, EU MDR, ISO 14971, ISO 5840, and ISO 22442
- Strong technical judgment when reviewing data, protocols, and reports
- Excellent communication skills and ability to work with cross‑functional teams and vendors
- Highly organized, detail‑oriented, and comfortable in a fast‑paced environment
- Willingness to work in cleanroom environments with bovine pericardium
Referrals increase your chances of interviewing at Cypress HCM by 2x
Seniority levelMid‑Senior level
Employment typeFull‑time
Job functionQuality Assurance
IndustryMedical Equipment Manufacturing
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