SysMind Tech
Supplier Quality engineer
SysMind Tech, North Haven, CT, United States
Technical/Functional Skills
• Medical Device Domain Experience
• Good understanding of ISO 13485, ISO19471, 21CFR PART 11 & 21CFR PART 820
• Knowledge of Gage R&R, QFD, MSA, AAA, Hypothesis Testing, RISK Mitigation, P-FMEA, Control Chart-Variable & Attributes
• Knowledge of Validation and verification activities (IQ/OQ/PQ)
Experience Required
• Bachelor's Degree in engineering or Technical Field or equivalent combination of education and work experience
• Min 3 years of related experience
• Demonstrated supervisory experience preferred. Engineering experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO19471, 21CFR PART 11 & 21CFR PART 820.
• Good communication and interpersonal skills.
• Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• ASQ CQE or other certifications preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Medical Device Domain Experience
• Good understanding of ISO 13485, ISO19471, 21CFR PART 11 & 21CFR PART 820
• Knowledge of Gage R&R, QFD, MSA, AAA, Hypothesis Testing, RISK Mitigation, P-FMEA, Control Chart-Variable & Attributes
• Knowledge of Validation and verification activities (IQ/OQ/PQ)
Experience Required
• Bachelor's Degree in engineering or Technical Field or equivalent combination of education and work experience
• Min 3 years of related experience
• Demonstrated supervisory experience preferred. Engineering experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO19471, 21CFR PART 11 & 21CFR PART 820.
• Good communication and interpersonal skills.
• Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• ASQ CQE or other certifications preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.