- Lead the quality management system to ensure compliance with ISO GMP FDA and industry standards.
- Oversee product quality and process controls across plastics healthcare and cosmetic manufacturing lines.
- Manage audits and regulatory compliance including internal customer and thirdparty certifications.
- Drive CAPA and rootcause investigations to resolve issues and prevent recurrence.
- Support new product introductions through quality planning validation and crossfunctional collaboration.
- Lead supplier quality activities including qualification monitoring and incoming material control.
- Champion continuous improvement using Lean/Six Sigma tools to enhance efficiency and reduce defects.
- Develop and mentor quality team members to build a strong quality culture.
Qualifications :
- Bachelors degree in Engineering Quality or related field; advanced degree or certifications (CQE CQA Six Sigma) are a plus.
- 3 years of quality management experience in plastics healthcare cosmetics or other regulated manufacturing environments.
- Strong knowledge of ISO 9001 ISO 13485 GMP and FDA/EU regulatory requirements.
- Proven experience leading audits managing QMS systems and maintaining compliance with customer and regulatory standards.
- Handson experience with CAPA rootcause analysis validation and risk management tools.
- Familiarity with process control statistical methods and quality metrics.
- Experience working with suppliers including qualification monitoring and corrective actions.
Additional Information :
Step into a company where innovation agility and energy fuel everything we do. As part of a global organization on a strong growth trajectory youll have the chance to shape the future expand your skills and grow your career in a dynamic forwardthinking environment.
What We Offe
- Up to three weeks of PTO in your first year plus 12 paid company holidays
- A comprehensive benefits package including medical dental vision Life/AD&D Short and LongTerm Disability and Identity Theft and Legal Protection
- Employee Savings Plan / 401(k) with a 100% employer match up to 6% of your base salary
- Health Savings Account with dollarfordollar company matching based on coverage level
- Flexible Spending Account (FSA) options
- Employee Assistance Health & Wellness Programs to support your mental health and wellbeing
- Flexible working hours
- Access to exclusive discounts on shopping entertainment and lifestyle perks
- A workplace committed to diversity inclusion and equal opportunity
If youre driven curious and ready to make an impact this is your moment. Join us and accelerate your career.
All information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Full-time
Lead the quality management system to ensure compliance with ISO GMP FDA and industry standards.Oversee product quality and process controls across plastics healthcare and cosmetic manufacturing lines.Manage audits and regulatory compliance including internal customer and thirdparty certifications.D...
- Lead the quality management system to ensure compliance with ISO GMP FDA and industry standards.
- Oversee product quality and process controls across plastics healthcare and cosmetic manufacturing lines.
- Manage audits and regulatory compliance including internal customer and thirdparty certifications.
- Drive CAPA and rootcause investigations to resolve issues and prevent recurrence.
- Support new product introductions through quality planning validation and crossfunctional collaboration.
- Lead supplier quality activities including qualification monitoring and incoming material control.
- Champion continuous improvement using Lean/Six Sigma tools to enhance efficiency and reduce defects.
- Develop and mentor quality team members to build a strong quality culture.
Qualifications :
- Bachelors degree in Engineering Quality or related field; advanced degree or certifications (CQE CQA Six Sigma) are a plus.
- 3 years of quality management experience in plastics healthcare cosmetics or other regulated manufacturing environments.
- Strong knowledge of ISO 9001 ISO 13485 GMP and FDA/EU regulatory requirements.
- Proven experience leading audits managing QMS systems and maintaining compliance with customer and regulatory standards.
- Handson experience with CAPA rootcause analysis validation and risk management tools.
- Familiarity with process control statistical methods and quality metrics.
- Experience working with suppliers including qualification monitoring and corrective actions.
Additional Information :
Step into a company where innovation agility and energy fuel everything we do. As part of a global organization on a strong growth trajectory youll have the chance to shape the future expand your skills and grow your career in a dynamic forwardthinking environment.
What We Offe
- Up to three weeks of PTO in your first year plus 12 paid company holidays
- A comprehensive benefits package including medical dental vision Life/AD&D Short and LongTerm Disability and Identity Theft and Legal Protection
- Employee Savings Plan / 401(k) with a 100% employer match up to 6% of your base salary
- Health Savings Account with dollarfordollar company matching based on coverage level
- Flexible Spending Account (FSA) options
- Employee Assistance Health & Wellness Programs to support your mental health and wellbeing
- Flexible working hours
- Access to exclusive discounts on shopping entertainment and lifestyle perks
- A workplace committed to diversity inclusion and equal opportunity
If youre driven curious and ready to make an impact this is your moment. Join us and accelerate your career.
All information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Full-time
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