Job description

Job Description:
We are seeking a Quality/Regulatory Engineer to lead our company in QA/RA requirements in both an Industrial and Medical capacity. As such, candidates should be familiar with ISO 9001 and ISO 13485 standards as well as FDA, CE and other Regulations. As the Quality/Regulatory Engineer, you will support both pre and post marketing activities related to the development, regulatory filing, and production of our products in both industrial and medical environments. You will support, contribute, and manage the overall Quality Management System, apply the requirements to our processes, products or services, and ensure compliance to applicable laws, regulations, and standards. You will actively lead quality improvement endeavors while working collaboratively with employees to resolve issues.

Duties and Responsibilities:
? Responsible for management of quality aspects of design controls and ensuring that there is clear traceability from design planning to commercialization.
? Ensure robust product testing is designed, developed and implemented.
? Review design history technical files for conformance to applicable requirements and regulatory standards. Review design changes to ensure documentation includes necessary justifications, validation and verification updates, risk assessment, etc
? Create risk management plans, perform product risk assessments, facilitate failure mode analysis and create final risk management reports
? Support Manufacturing line, investigate and address quality issues.
? Author, collaborate, and approve Quality System documentation including change orders, DHF, DMR, DHR, labels and labeling, etc.
? Conduct internal, vendor and process audits
? Interface with suppliers to resolve quality issues
? Assist in training personnel on all aspects of the Quality System and regulatory standards

Required Experience/Skills:
What experience should applicants have before submitting their resumes? Certain highlights might be:
? 5+ years of Quality Engineering experience preferably with technical knowledge and experience in Quality Assurance and/or regulatory functions as well as the medical device industry
? ISO 9001, ISO 13485 and cGMP (21 CFR 820) experience is a plus
? Strong self-starter, effective team player
? Effective oral, written and presentation skills
? Knowledge of Microsoft Office Suite (Word, Excel, PowerPoint, Teams)

Job Type: Full-time

Salary: $80,000.00 - $100,000.00 per year

Schedule:

• Monday to Friday

Ability to commute/relocate:

• North Tonawanda, NY 14120: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Medical Device: 2 years (Required)

Work Location: In person

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