Quality Assurance Investigator

Quality Assurance Investigator

Responsibilities:

• Focus on nonconformance (deviation) investigations.
• Perform all compliance related tasks vital to complete investigations and implementation of robust corrective actions for supporting manufacturing operations.
• Plays a vital role in ensuring the highest quality and safety standards of our medical device products.
• Supporting all stages of manufacturing with conducting and writing incidents and deviation investigations.
• Work cross-functionally with Operations and various support groups (Quality and Engineering teams) to investigate root causes, implement effective corrective and preventative actions, and perform thorough product impact analyses.
• Independently author and resolve deviations in order to meet production and product release requirements
• Communicating across multiple groups and levels to drive deviation closure
• Identifying interdepartmental process improvements and working cross-functionally to-implement them
• Utilizing advanced root cause analysis techniques and technical impact analyses during the deviation investigation process
• Managing multiple priorities either independently or as part of a team in order to meet key deadlines and communicate issues and progress across all levels of organization
• Communicating (both written and verbal) progress and updates across multiple levels of the organization
• Performing more complex deviation investigations

Requirements:

• 4-year degree in the sciences background is required for this role.
• Previous experience with proper GDP, Good Documentation Practices will be helpful.
• Excellent written and verbal communication skills with demonstrated ability to work cross-functionally across different functional groups and demonstrated ability to prioritize and manage multiple tasks effectively and efficiently.
• Strong root cause analysis experience and technical writing experience
• Diligent with strong analytical and critical thinking skills
• Organized and disciplined to manage multiple tasks and priorities
• Adept and able to work independently and as an engaged team member
• Utilize computerized systems for daily performance of tasks. Computer Skills include Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Express energy, show accountability, have ability to multi-task and work in a fast-paced, quality-rich environment

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With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.

Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.