EDUCATION, EXPERIENCE, QUALIFICATIONS AND SKILLS:
- Bachelor’s degree preferred or equivalent job experience is required
- 5 years of experience in an FDA regulated manufacturing environment
- Working knowledge and experience with FDA 21CFR820 and ISO 13485 and FDA
- Industry or discipline specific certification a plus (CQE, CQA, CMQ/OE, Lean, Six Sigma, etc)
- Ability to accurately perform mathematical calculations, read and produce graphs, and work with all forms of numbers
- Ability to manage problems involving several concrete variables in standardized situations
- Excellent computer skills including but not limited to Microsoft Office
- Strong planning and organizational skills
- Strong verbal, written and interpersonal communication skills
- Must have a positive attitude while maintaining flexibility
- Team-player with ability to facilitate meetings with cross-functional teams
QUALITY AND REGULATORY REQUIREMENTS:
- Report status and any needed improvement of the quality system to the Director or VP of QA/RA
- Responsible for ensuring review and implementation of new and updated regulations, standards, guidance documents, and other regulatory requirements as applicable.
- The Quality Manager, in conjunction with the Director and/or VP of QA/RA and the site’s MWER, has the authority to define methods and mandatory procedures, and to reject procedures and products that do not conform to company, regulatory, or customer quality standards
- Quality system knowledge including the quality manual, quality policy, and applicable procedures and work instructions
- Define, document, and review the quality system and policy
- Ensure the quality policy is understood, implemented, and maintained at all levels of the organization
- Ensure the quality system is effectively established and maintained per FDA, ISO 13485, European Union MDD and MDR, Japanese Ministry of Health and Welfare Regulations and Canadian Medical Device Regulations
- Define and document responsibilities and authorities for work that affects Sterilization and Quality Systems
- Identify and provide adequate resources for support of the Regulatory Department and overall Quality System compliance
PHYSICAL REQUIREMENTS:
NOTE:The inability to perform any of the following physical requirements does not preclude an applicant from consideration unless, following an individualized analysis, it is determined that the physical requirement is an essential job function and the applicant is unable to perform such function with or without reasonable accommodation
Please refer to the Essential Duties and Responsibilities.
At Aspen Surgical, we strive to build a diverse work force through equal opportunity employment that embraces and leverages the differences that each individual has to offer. This job description is only a summary of the typical functions of the job and not intended to be an exhaustive list of all job responsibilities, tasks, and duties.Aspen Surgical Products, Inc. is an equal opportunity Employer F/M/Disability/Vet/Sexual Orientation/Gender Identity.
