Quality Assurance Scientist

Organization
Accelerate Diagnostics
Job Location
3950 S Country Club Road
Suite 470
Tucson, AZ 85714
Benefits

Health, Vision, Dental, 401k, ESPP, Relocation, On-site Gym, Weekly Yoga, Friday catered lunches, Employee discounts, 10 paid holidays, On-site car wash, dry cleaning, pet insurance, legal assistance, HSA, FSA, Identity theft, Short/long term dissability, Employee assistance program, Basic and Voluntary LIfe/AD&D insurance, and term Life Insurance

Job Description

Position Title: Quality Assurance Scientist
Position Overview:
This is a highly technical quality position responsible for decision-making on product issues, design and development requiring critical analytical thinking. The desired candidate has a strong scientific background, knowledge of quality processes, attention to detail and strong organizational and communication skills. Roles and
Responsibilities: - Responsible for Technical Decision-Making for Product Issues - Performs detailed data review. - Participates and reviews in risk assessment for products and processes. - Supports risk analysis process for technical accuracy for various QMS, e.g., nonconformances, investigations, CAPAs, etc. - Represents Quality in Design and Development including process changes. - Provides key technical guidance and oversight to Design and Development process including design change control. - Evaluates changes orders - Provides technical guidance and quality assurance support in the transfer of new products and process to maintain quality standards. - Evaluates and edits Technical Protocols and Reports - Performs critical review of documentation for qualification, verification, and validation activities. - Provides guidance on gaps identified from the review and actively participates to determine potential remediation activities. - Assures design and development, and manufacturing operations are performed in compliance with QMS as well as domestic and international regulations. - Provides scientific approach and Quality Assurance direction to the approval of the QMS documents such as batch records, protocols, procedures, qualification, and validation reports.- Enforces critical analytical thinking in the investigation management process specifically during root cause analysis, risk assessment evaluation and corrective and preventive actions determination to guarantee that gaps are properly addressed. - Provides scientific input into investigations using a systematic approach for the opportunities identified to ensure root cause and CAPAs are aligned. - Assists management during internal and regulatory agencies inspections. - Performs trend analysis to provide recommendations to improve the process and/or product quality. - Supports the Annual Product Review elements for Quality events of manufacturing. - Participates as quality representative or liaison in site projects.
 

Requirements

Qualifications:- Master Degree in Science (Chemical, Biology or Microbiology) with five (5) years of experience in Quality Assurance responsibilities in a medical device or equivalent regulated industry- Strong knowledge of relevant GMP, FDA, EU regulations and the ability to interpret and apply them for intended use.- Self-motivated and team work oriented.- Technical and scientific capability to make firm decisions and recommendations.- Excellent interpersonal skills and the ability to interact with people at all levels.- Effective communication Skills.- Sense of urgency and analytical thinking.- Proficient knowledge of computer systems (Microsoft Office etc.) and applications like PLM, QMS and ERP.- Solid ability for analyzing data and detecting deviations, trends, and inconsistencies.- Proficient knowledge of problem solving and root cause analysis methodologies (e.g. Kepner Tregoe).- Technical Writing experience, a plus.

How to Apply
About Our Organization

Accelerate Diagnostics purpose is to develop revolutionary technology for the microbiology lab.

Technologies and tests that accelerate lab results and drive better clinical outcomes for patients with serious infections.