Hi, I’m Sheila Jones, a Validations consultant and Chief Operating Officer of TraceMatrix Inc (where even the CEO’s get their hands dirty… that’s NOT our ‘official’ byline, I might add). I came across your resume online and felt your skill-set closely allied those we are currently seeking for placement with our Pharmaceutical and Medical device industry validations teams. Please take the time to review the following TraceMatrix position announcement. If you are seeking a change of employment (or know of someone with similar skills who is seeking such an alternative) please forward your current resume and hourly rate expectations to sheila.jones@TraceMatrix.com.
Feel free to call or email me with any questions you may have regarding this position or future opportunities with TraceMatrix Inc. I look forward to speaking with you soon.
Medical Device Validation Protocol Writing and Execution
TraceMatrix Inc. is a Technical Engineering and Scientific quality consulting firm serving the Pharmaceutical and Medical device manufacturing industries. We are seeking Short Term Contract Validations personnel with previous Medical Device manufacturing, regulatory, quality assurance or quality control (QA/ QC) testing experience.
The candidates will work with our TraceMatrix Team at the client site near Portland Oregon in writing Validations qualification protocols and executing the testing associated with Medical Device Manufacturing equipment.
Qualification Testing and protocol development (technical writing) associated with medical device manufacturing equipment and processes.
Data collection and qualification testing execution: Collect physical test data in an efficient and cost-effective manner in accordance with GMP standards.
Write validation, qualification and commissioning protocols.
Compile, generate and maintain orderly documentation associated with engineering documentation in support of project efforts.
Prepare for on-site installation of equipment (requiring examination of building layout, anticipating difficulties, gathering materials.
Effectively and cross-functionally Coordinate on-site work with project managers, contractors and field personnel to homogenize interdependent schedules and obtain customer approval and acceptance.
Minimum education of technical Associates degree or equivalent experience (Bachelors degree is preferred).
Previous technical, testing, scientific, or regulatory experience with medical devices.
Knowledge of Medical Device manufacturing processes and applicable cGMP / GLP requirements.
FAMILIARITY with one or all of the following TECHNICAL AREAS PREFERRED:
Familiarity with Medical Device applicable FDA regulations and ISO standards.
Preference will be given to candidates with previous audit experience.
Competency in reading drawings, P& ID’s and other engineering aspects related to process design or mechanical equipment layouts.
Familiar with industrial Corrective and Preventive Actions (CAPA) and associated resolutions.
This is a three (3) to six (6) month contract position in Portland, Oregon.
Preference will be given to local candidates.
Candidates must be flexible to work overtime and weekends if required.
Performing functions at the client site requires direct client contact. Thus the candidate represents the company, and will be held accountable for ensuring customer satisfaction. Candidates must perform their tasks in a professional and conscientious manner treating all coworkers and clients with respect.
Please forward your resume in MS-Word format to Sheila.Jones@TraceMatrix.com for immediate consideration.