Sr. Manager, Quality Assurance
Description
Attindas Hygiene Partners designs, manufactures, and markets absorbent hygiene products. The company sells adult incontinence and infant diapers, among other products, into the healthcare, retail, and direct-to-consumer channels under brands including Attends, Indas, and Comfees as well as a wide range of private label brands for retailers.
Mission: We champion health, dignity and comfort.
Vision: To be a global leader in absorbent hygiene by meeting consumers’ diverse needs through effective, affordable and widely available personal care solutions.
Our Values: Caring, Agile, Innovative, Unique, Personal, Genuine
Job Summary:
The Site Sr. QA Manager is responsible for the Sites QMS system and all quality related activities.
Quality Management System
- Ensure development, implementation, management and maintenance of the Quality Management System (QMS) for the site in compliance to the Attindas Hygiene Products (AHP) corporate QMS.
- Responsible for maintaining certifications and ensuring that the site Quality Management System (QMS) complies with AHP Corporate, Regulatory (i.e. FDA, etc.), ISO 13485 and Customer standards.
- Develop site Quality Strategy, Goals & Objectives to incorporate corporate quality strategies and site specific requirements.
- Conduct Quality Systems and GMP training for all new employees
- Assure that there are no significant interruptions to the business due to Supplier quality or compliance issues.
- Manage all quality audits both internally and externally
- Pursue action and recommend disposition in the event abnormalities are identified
- Initiate product holds and maintain a status & inventory of hold products
- Provide quality leadership, independent expertise, objective assurance, and advisory services designed to add value to the organization
Manages All Site QA Personnel, Activities and Operations.
- Active participant on the site leadership team
- Manage all site Regulatory requirements
Process Control Strategy, Product Testing & Reporting
- Lead the development and support the implementation of the sites Process Control Strategy.
- Key Metrics & Reporting: Annual/Quarterly/Monthly quality meetings and reviews
- Transform the site from a Quality Control to Quality Assurance through systemic system development, training and continuous improvement.
QA Culture & Capability Building
- Develop, lead and role model a "Quality Culture" for the site
- Develop and lead the effort to build QA Capability throughout the site
- Provides site wide quality systems training, coaching and support
Key Responsibilities
- Quality Management System Development, Implementation, Ownership & Compliance
- QA Leadership / Management / Capability Building (Team & Site)
- Process Controls / Product Testing
- Continuous Improvement
Required Qualifications/Professional Experiences
- Bachelor of Science in Quality, Engineering or a Technical discipline
- Minimum of 7-10 years in a Quality position with demonstrated quality systems leadership
- Broad and in-depth knowledge of quality control techniques
- Knowledge and experience of product evaluation methods
- 5+ years Management Experience
- Knowledge of statistics used in quality control. (Green Belt training or equivalent)
- Knowledge and experience in statistical process control and process capability techniques
- General knowledge of data reporting and data analysis techniques
- Strong oral and written communication skills
- Ability to work & lead a large team independently
Preferred Qualifications/Professional Experiences/Years of Experience:
- Master’s Degree of Science in Quality, Engineering or a Technical discipline
- Knowledge of disposable nonwovens converting processes preferred
- Previous working experience in a GMP/Regulated environment preferred
- Demonstrated knowledge of statistics
- Previous Six Sigma and Lean Manufacturing experience preferred
- Working knowledge of 21 CFR820 and / or ISO 13485
Attindas is an equal opportunity employer. Qualified applicants will be considered without regard to age, race, color, sex (including gender identity or expression, sexual orientation, and pregnancy), marital status, religion, national origin, genetic information, disability, or veteran status.