We are seeking a highly skilled Quality Engineer to develop and implement systems ensuring that our products and services meet or exceed customer expectations and regulatory requirements, including those of the US Food and Drug Administration, Health Canada, and European MDD/MDR. This role will focus on enhancing our quality management system procedures and directly contribute to maintaining and improving our quality system processes, including CE Technical Files, Risk Management Files, Clinical Evaluations, Post Market Surveillance, and Periodic Safety Reports.
Key Responsibilities:
Identify opportunities and recommend improvements to product design and manufacturing processes
Provide ongoing quality engineering support throughout the product lifecycle, including risk management, design changes, and CAPA investigations
Perform engineering analysis related to component specifications and root cause analysis
Collaborate with suppliers and manufacturing personnel to reduce defects and improve yield
Participate in supplier selection, qualification, and quality audits
Develop processes for generating key metrics and indicators for the Quality Department
Conduct periodic trend analysis and provide impact analysis to ensure product quality, patient safety, and regulatory compliance
Implement problem-solving methodologies to reduce defects
Provide guidance on product and process improvement projects
Ensure validation of key design inputs including usability, reliability, and performance
Plan and assure product and process quality according to best practices
Implement controls based on the risk management process
Maintain knowledge of relevant quality and regulatory standards
Create technical documentation to support regulatory requirements including Clinical Evaluation Reports and Post Market Surveillance Reports
Support computer system validation and stay current with validation regulatory requirements
Participate in special projects and perform other duties as required
Minimum Work Experience:
Typically 5 to 7 years of progressively responsible professional experience in quality engineering or a related field
Preferred Education:
Bachelor’s Degree or global equivalent in a related discipline
Industry certifications may be required
General Skills & Competencies:
Strong understanding of industry practices and regulatory requirements
Proficiency with tools, systems, and procedures related to quality engineering
Excellent planning, organizational, decision-making, and problem-solving skills
Strong verbal and written communication skills
Effective presentation and public speaking abilities
Good interpersonal and conflict resolution skills
Ability to build productive partnerships at all levels and resolve complex issues effectively
Specific Knowledge & Skills:
In-depth knowledge of medical device regulations including ISO 13485:2016, 21CFR820, MDR, and other global standards
Proven experience with problem-solving methods and tools
Understanding of the risk management process and its implementation in product development
Experience in product and process validation, and the development of testing processes
Practical experience with statistical tools and techniques
Strong background in supplier quality and development
Knowledgeable in computer system validation and related regulatory requirements
If you are a motivated individual with a keen eye for detail and a passion for ensuring product quality and compliance, we invite you to apply for this exciting opportunity.
Pay Details: $30.00 to $40.00 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to />Physical Therapist The Physical Therapist is forward-thinking who excels at assessing patients' strengths and weaknesses and devising creative and effective treatment plans. Therapists must practice discretion & maintain patient confidentiality. Must operate a high-energy...
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