Internal Quality Assurance Lead ensuring integrity and quality of assessment in IOSH Academy programmes. Providing academic guidance to tutors and overseeing quality assurance.
About the role
- Quality Engineer leading supplier quality management and process improvement in medical device production. Monitor supplier quality, manage risks, and ensure compliance with standards.
Responsibilities
- Support Quality Systems including change control, supplier non-conformances, ASL management, Quality Agreements and department procedures and system, as assigned.
- Perform and Support supplier/ EM quality evaluations and/or audits, development of quality agreements, and other quality related activities impacting supplier.
- Lead activities associated with resolving supplier quality issues. This includes working with suppliers and internal partners to perform root cause analysis/failure investigations, identifying and implementing corrective actions, and monitoring for effectiveness.
- Lead activities associated with supplier risk management. This includes working with suppliers to identify areas of high risk within their processes; establishing, monitoring and implementing supplier risk mitigation plans; participating in supplier risk management projects; and ensuring management awareness of risks, gaining support for mitigation efforts and tracking progress.
- Lead activities associated with supplier process improvement. This includes working with suppliers to identify sources of variation within their processes; implementing process controls to improve process capability; and driving implementation of best practices.
Requirements
- Bachelor's Degree is required; Master’s Degree is preferred
- Generally requires 4 – 6 years of work experience in a GMP and/or ISO regulated industry
- Experience in the medical device / pharmaceutical industry is preferred
- Engineering or science field of study is preferred
- Excellent communication, teamwork, and problem-solving skills are required
- Expertise in all aspects of quality event investigations such as root cause analysis followed by comprehensive corrective action suggestions
- Experience with machining, injection molding, metal processing such as passivation, anodizing and heat treating, and/or electronics assembly are preferred
- FDA CFR and ISO regulations knowledge is required, with FDA CFR Part 820 and ISO 13485 knowledge preferred.
- Auditing background is a plus
- Six Sigma, Lean, American Society for Quality (ASQ) certification and professional licenses are preferred
- Strong statistical analysis skills are preferred
- Fluency in English is required
Benefits
- Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company’s long-term incentive program.
- Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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