Quality Assurance Specialist

2 weeks ago

Milpitas, California, United States Innova Solutions Full time

Innova Solutions is currently seeking a Quality Assurance Specialist.

Position Type: Contract

Duration: 6 months

Location: Onsite

As a Quality Assurance Specialist, your role will encompass:

Key Responsibilities

  • Developing and overseeing a comprehensive validation strategy, including site-specific and product-specific validations.
  • Creating, reviewing, and supporting validation documentation to enhance process reliability.
  • Assisting in the management of the complaint handling process, including thorough analysis and investigation.
  • Leading and supporting initiatives aimed at improving reliability and processes from a quality standpoint.
  • Establishing and maintaining process controls and Statistical Process Control (SPC) for designated production operations.
  • Contributing to the Corrective and Preventive Action (CAPA) program.
  • Facilitating training initiatives to communicate Quality System standards across the organization.
  • Evaluating product designs and process documentation for quality attributes, including manufacturability and reliability.
  • Ensuring compliance with standards for sterilization, biocompatibility, and safety.
  • Reviewing and providing insights on validation protocols and reports, including vendor qualification processes.
  • Assisting in the creation and upkeep of product risk management documentation.
  • Participating in design verification testing and validation of testing methodologies.
  • Recommending requirements for inspections and testing strategies.
  • Engaging in investigations of failures to identify root causes and implement corrective measures.
  • Evaluating new suppliers and collaborating with them to ensure quality control measures are in place.
  • Conducting audits of Design History Files and collaborating with cross-functional teams to address documentation discrepancies.
  • Implementing best practices in quality engineering, including statistical analysis and root cause investigation.
  • Supporting material-related processes with suppliers to ensure timely resolution of non-conformances.
  • Driving continuous improvement efforts through detailed analysis of non-conformances and developing compliant solutions.
  • Managing Returned Goods Authorization (RGA) processes.
  • Representing the Quality function within production and service teams.
  • Implementing risk evaluation techniques in accordance with ISO 14971.
  • Maintaining compliance with all aspects of the Quality Management System to ensure regulatory adherence.
  • Understanding and following the Quality and Environmental Health and Safety (EHS) Policies.

Qualified candidates are encouraged to submit their applications for consideration. We are actively interviewing for this and similar roles. Additionally, we offer a referral bonus program for successful placements.

Compensation and Benefits:

Pay Range: $42/hr - $50/hr

*Compensation will be determined based on various factors, including education, experience, and specific job responsibilities.

Benefits: Innova Solutions provides benefits (subject to eligibility) including medical coverage, dental and vision insurance, 401(k), health savings accounts, life insurance, and more.

About Innova Solutions: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals globally and generates nearly $3 billion in annual revenue. We deliver strategic technology and business transformation solutions, enabling our clients to excel in their respective fields.

Recent Recognitions:

  • Ranked as one of the largest IT consulting staffing firms in the USA.
  • Recipient of the ClearlyRated Client Diamond Award.
  • Recognized as a leading certified MBE company.
  • Advanced Tier Services partner with AWS.

Innova Solutions is an Equal Opportunity Employer committed to creating a diverse environment free from discrimination. We encourage all qualified candidates to apply.

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