Now Hiring: Quality Specialist III
Grow Your Career with Outstanding Employee Benefits!
Full-Time| On-Site| West Chester, PA | $27.00 - $29.00 per hour
Join Altus Spine
At Altus Spine, we develop innovative spinal implant and surgical solutions where quality, precision, and patient safety are at the center of what we do.
We are seeking a Quality Specialist III to have the ability to back up, as needed, all essential functions of the Quality Specialist I & II, including but not limited to: conducting repetitive inspections of medical devices with calibrated instruments and equipment, completing Device History Records, inspecting packaged and labeled devices, conducting cycle counts of quarantined inventory, facilitating non-conformances & RMAs, and participating in inspections, internal audits, and certification audits.
Your Impact
- Utilize magnification to read and verify small-font laser etching.
- Help devise and improve methods of customer feedback to facilitate continuous improvement and post-market surveillance.
- Work closely with Engineering to provide traceability between customer feedback and the design change control process.
- Per internal procedure, evaluate initial risk and escalate complaints to QA/RA and Engineering for final disposition and resolution.
- Submit eMDRs (electronic medical device reports) to the FDA and maintain complaint files per 21 CFR 820.198.
- Facilitate monthly reviews of product complaints with management.
- Facilitate document control of the labeling database, as well as GS1 and GUDID submissions.
- Under the direction and oversight of Quality Management, serve as an eQMS (electronic quality management software) document control coordinator and SOP/WI training facilitator.
- Maintain working knowledge of medical device regulations, including but not limited to ISO 13485, ISO 14971, 21 CFR 820.90, and MDSAP, as well as 21 CFR 820 cGMP requirements.
- Assist with administrative tasks required to bring products to market, including 510(k) submissions and management review meetings.
- Serve as QA Lead, providing training to Quality Specialist I and II roles and assisting with troubleshooting activities.
- This position does not have any supervisory responsibilities.
What You Bring (Qualifications)
- Master's Degree; Bachelor's degree plus 3+ years; Associate’s degree plus 5+ years; High School plus 10+ years of Medical Device, Pharma, or clinical experience; or, an equivalent combination of education and experience.
- Must have valid Drivers License.
- Experience supporting a QMS throughout audits/inspections desired.
- Ability to use calipers, micrometers, RAM overlay, comparators, gages, and other quality inspection instrumentation.
- Must thrive in an environment that facilitates investigations with the desire to discover root cause.
- Proficient with MS Office.
- Familiar with basic ERP/MRP functions.
- Highly organized
- Well mannered and personable. Experience with direct conflict resolution desired.
- Ability to communicate to customers and internal employees to quickly disseminate information in meeting settings.
Altus Spine is proud to be an Equal Opportunity Employer. Altus Spine does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any basis covered by applicable law. All employment is decided on the basis of qualifications, merit and business need.
*Principals only. Recruiters please do not apply on behalf of your candidates to Altus Spine job posts. All applications and/or contact information submitted are kept on file and are the property of Altus Spine. Please note recruiting fees will not be honored with candidate applications submitted by recruiters.