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Quality Assurance Engineer

2 months ago

Gillette, Wyoming, United States inSync Staffing Full time

Compensation: $50.00-$63.50/hr - Paid Weekly

Schedule: Monday to Friday, 8am to 5pm

Contract Duration: 6 months (temporary position)

Required Experience: Medical device catheter expertise

Key Responsibilities:

1. Initiate, author, investigate, and resolve Non-conformances.

2. Provide equipment support, including review of Installation Qualification, Operational Qualification, and Performance Qualification, along with product support as necessary.

3. Conduct investigations related to Endotoxin and Bioburden.

Daily Responsibilities: Collaborate with the team to ensure tasks are completed within established timelines.

Desired Personality Traits: A proactive attitude towards learning and team support, ability to thrive in a fast-paced manufacturing environment, and strong attention to detail.

Interview Process: Following the initial resume submission, candidates will undergo a video screening followed by an on-site interview with Quality Management and Senior Quality Staff.

Qualifications:

  • Bachelor's degree in Engineering or a related field with a minimum of 5 years of relevant experience; or a Master's degree in Engineering with at least 3 years of relevant experience; or an equivalent combination of education and experience.
  • Experience with catheters, endovascular, or neurological devices is highly preferred.
  • Proven experience in addressing supplier or process issues (CAPAs, NCMR/NCRs, SCARs, etc.).
  • Familiarity with Endotoxin investigations, Bioburden, and Environmental programs is advantageous.
  • In-depth knowledge of quality system requirements (FDA 21 CFR Part 820, ISO 13485 or ISO 9001) and risk management standards.
  • Exceptional communication skills, both written and verbal.
  • Ability to conduct thorough and meticulous document reviews.
  • Skilled in writing clear, concise, and well-structured technical documentation focused on failure investigations and inspection procedures.
  • Capable of managing multiple tasks concurrently with precision.
  • Proficient in Microsoft Office applications.

Essential Duties:

  • Provide Quality input to define necessary validations for significant process changes on commercially launched products.
  • Support the non-conforming materials program, including authoring and leading investigations.
  • Collaborate with team members to establish validation requirements, specifications, testing, and acceptance activities, and manage validation protocols and reports.
  • Analyze data through hypothesis testing, normal distribution, and process capability analysis to assess product/process quality.
  • Create and update quality assurance procedures to ensure compliance with evolving regulations and guidance documents.
  • Lead training sessions on procedures to promote adherence to Quality Systems and Regulations.
  • Work with laboratories for routine product testing or root cause analysis related to testing failures or deviations.
  • Conduct systematic root cause investigations and recommend actions to prevent recurrence.
  • Engage directly with suppliers to qualify and maintain approved supplier status, including evaluating supplier notifications of change.
  • Perform statistical analysis of manufacturing data and quality processes, and generate reports based on quality documentation.
  • Review Design Change Orders involving product or process changes to ensure alignment with company procedures and quality system compliance.
  • Conduct and assess Risk Management evaluations on product and process changes.
  • Perform failure mode effect analysis on products.
  • Support projects, including product enhancements, in alignment with corporate objectives.

Employee Benefits:

  • Health insurance
  • Health savings account
  • Dental insurance
  • Vision insurance
  • Flexible spending accounts
  • Life insurance
  • Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.