What are the responsibilities and job description for the Manager, Quality Systems position at Enable Injections?
Location: Onsite
Status Type: Full Time
QUALIFICATIONS
Required:
- Bachelor’s Degree in Scientific discipline
- Minimum of 7 years of GXP experience
- Minimum of 5 years of experience in the medical device or pharmaceutical industries
Preferred:
- Certified Quality Auditor (CQA)
- Six Sigma or Project Management Professional certification is a plus
Skills & Competencies:
- Ability to lead quality systems group by providing daily direction, resource planning, and develop longer term strategies
- Establish departmental metrics and goals in support of organizational strategic goals
- Prefer SAP experience
- Strong knowledge of medical device manufacturing systems and methods
- Strong ability to collaborate cross-functionally
- Knowledgeable in implementing and managing Quality Assurance systems and procedures
- Familiar with medical device manufacturing systems and methods
- Possess a good balance of technical experience, analytical thinking, and communication skills for resolving issues internal and external to the organization
- Competent with word processing, spreadsheets, and statistical analysis software packages (preferably Word, Excel, and Minitab)
Physical Requirements:
- Must be able to remain in a stationary position for extended periods of time
- Must be able to gown to access the controlled areas
- Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.
RESPONSIBILITIES:
- Manage several Quality system processes: documentation system, archive, change control, internal audit, training, and audit support
- Lead and support process improvement & efficiency projects, as necessary
- Able to lead audit teams to support external customers, regulatory bodies, and notified body audits. Responsible for developing and submitting responses
- Implementation and maintenance of requirements needed to conform to ISO 13485, CFR 820, and MDR
- Review/approval for Quality procedures and records
- Reporting routine Quality metrics to the Senior Management team
Pay: From $96,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
Salary : $96,000