Job Announcement: Quality Assurance Professional - Medical Device

Company Name:

Strata Skin Sciences

Job Location:

Carlsbad, CA

Position Title:

Quality Assurance Professional

Position Type:

Open (contract, contact to perm, permanent)

General Job Description:

Provide QA support for a Medical Device Laser company. We have immediate need for 1 to 2 QA professionals who have some combination of the background listed below. Job Title and compensation will be commensurate with experience. We are a small company, and as such, need people who can cover multiple areas of QA responsibility with ability to not only set up QA systems, but also perform day to day operations

Responsibilities:

  • Manage and maintain customer complaint process, including data analysis for trending. Ensure all sources of complaint data are evaluated for input to the system.

  • Perform Adverse Event Reporting both Domestically and Internationally

  • Manage and maintain Corrective Action (CAPA) process, including data analysis for trending.

  • Assist the QA/RA Director as needed in Leading and Managing audits by external regulatory authorities

  • Act as Quality Assurance liaison to local Engineering, Purchasing, Marketing, and Manufacturing.

  • Assist in the maintenance of product Technical Files and Design History Files

  • Lead and Manage Internal audit program

  • Manage customer returns process.

  • Manage employee Quality System and GMP training

  • Participate on product design teams as QA team member

  • Perform Annual Post Market Trending

  • Host MRB meetings to ensure timely disposition of NCMRs

  • Perform periodic random Quality Audits

  • Perform supplier qualification / Requalification and Maintain ASL

  • Perform quarterly supplier monitoring,

  • Prepare and disposition non-conforming material reports

  • Manage Suppliers and Supplier Corrective Actions

  • Maintain Calibration System and Ensure appropriate actions are taken for out of calibration equipment

  • Perform Device History Record (DHR) Reviews and Approvals

  • Create and Revise SOP’s – WI’s in support of QMS and initiate ECO’s

  • Create and revise Inspection test plans

  • Perform First Article Inspections

  • Perform incoming inspection

  • Initiate process improvement in Quality Systems for long term productivity gains

Qualifications:

  • Minimum of 2 years working as a QA professional in a Medical Device company. BS degree (Engineering preferred). Good understand of 21 CFR part 820 and ISO 13485 requirements, GMP and GDP. ASQ certification(s) a plus

Application Information & Contact (How to Apply)

To apply, contact Mark Perkins via email at mperkins@strataskin.com