Quality Assurance Specialist

2 weeks ago


Milpitas, California, United States Innova Solutions Full time

Innova Solutions is actively 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 system, including analysis and follow-up actions.
  • Leading initiatives aimed at improving reliability and processes from a quality standpoint.
  • Establishing and maintaining statistical process controls for designated production workflows.
  • Contributing to the corrective and preventive action (CAPA) initiatives.
  • Facilitating training programs to ensure all personnel understand Quality System requirements.
  • Evaluating product designs and process documentation for quality attributes, including manufacturability and reliability.
  • Ensuring compliance with standards for sterilization, biocompatibility, and safety.
  • Reviewing protocols and reports, managing vendor qualifications, and overseeing testing processes.
  • Assisting in the creation and upkeep of product risk management documentation.
  • Supporting design verification testing and validation of testing methodologies.
  • Recommending requirements for inspections and testing, including sampling strategies.
  • Engaging in investigations of failures to identify root causes and implement corrective measures.
  • Evaluating new suppliers and collaborating with them to enforce quality controls.
  • Conducting audits of Design History Files and collaborating with teams to rectify documentation discrepancies.
  • Implementing effective quality engineering practices, including statistical analysis and root cause investigation.
  • Participating in material-related processes to ensure timely assessment of non-conforming products.
  • Driving continuous improvement initiatives through detailed analysis of non-conformances and implementing compliant solutions.
  • Managing Returned Goods Authorizations (RGA) processes.
  • Representing the Quality function within the Production and Service teams.
  • Implementing risk evaluation techniques in accordance with ISO 14971.
  • Maintaining compliance with the Quality Management System to ensure regulatory adherence.
  • Understanding and following the Quality and EHS Policies.

Qualified candidates are encouraged to submit their applications for consideration. We are conducting interviews 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) such as 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 around 50,000 professionals globally and generates nearly $3 Billion in annual revenue. We offer strategic technology and business transformation solutions to empower our clients.

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 providing a work environment free from discrimination and harassment.



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