Senior Quality Assurance Engineer - Onsite
Location: Portage, MI 49002
Pay Rate: $56.66/hr. - $66.66/hr. W2
Contract Duration: 12 Months
Shift (if applicable): M-F 8:00 AM - 5:00 PM
**Must have experience in a regulatory environment
Description/Comment:
Implement quality standards, ensure and execute compliance on every stage of the process. Assess potential risks, ensures compliance and gives recommendations. Takes responsibility for all quality control aspects of the process (laboratories studies, clinical research, testing, operations, raw materials, production, finished product or services). Facilitates audits and regulatory inspections. Coordinates quality trainings. This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience. This job typically requires a degree or equivalent and no experience.
Additional Job Details:
Job Summary:
Contractor - Senior Quality Assurance Engineer
We are seeking a dedicated Senior Quality Assurance Engineer with strong Quality System experience to join our integration team. In this role, you will support post-market surveillance, complaint handling, and continuous improvement activities while ensuring compliance with regulatory requirements. As part of a recent acquisition of a software technology company, this individual will support activities to integrate this new business with an existing medical device quality system. Experience with software products and non-medical devices is preferred to assist in the post-market assessment activities and quality system integration.
Key Responsibilities:
* Complaint Management and Issue Resolution:
o Manage and analyze customer complaints, warranty claims, and field failures to identify root causes, drive effective corrective actions, and improve product reliability.
o Support the development and assessment of product return process as part of complaint handling.
o Collaborate with cross-functional teams to ensure timely closure and documentation of complaints.
o Develop and deliver regular trend analyses and reports to identify systemic issues and areas for improvement.
* Quality System Management:
o Support the maintenance and continuous improvement of the Quality Management System (QMS) in alignment with industry standards (e.g., ISO 9001, ISO 27001, TL 9000).
o Create, review, and update quality procedures, work instructions, and best practices.
o Consult with various Post Market stakeholders to create and propose process maps that may be used as part of procedure creation.
* Qualifications:
o Bachelor's degree in Engineering, Life Sciences, or related field (or equivalent experience).
o 3+ years of experience in Quality Engineering within the medical device, pharmaceutical, or related regulated industry.
o Strong knowledge of quality system regulations (ISO 13485, 21 CFR Part 820) o Experience with complaint handling, CAPA, and nonconformance management.
o Excellent problem-solving, data analysis, and communication skills. This contractor role offers the opportunity to play a vital part in our organization's growth and innovation, ensuring a seamless and compliant integration of Quality Systems across both companies.
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.
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