Manager, Supplier QualityApply Now Current Employee? Job ID 17000MVB
PURPOSE AND SCOPE:
Responsible for developing, implementing, and monitoring supplier quality programs for products. Ensures that company philosophy is understood and adhered to by partners. Plans, conducts and documents supplier and co-manufacturer audits and resulting corrective actions. Develop new and improved business process flows for supplier and ingredient approval programs. Ensure recurring document collection and review activities are scheduled and conducted as required.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Manage the tactical execution of short- and long-term objectives through the coordination of activities with a direct responsibility for results, including costs, methods, and staffing.
- Ensures Supplier Quality Management (SQM) procedures are clearly defined and implemented to fulfill regulatory and business requirements.
- Identifies areas for continuous improvement and facilitates establishment of appropriate SQM related priorities.
- Provides periodic (weekly, monthly, quarterly and annual) reports describing the state of the SQM process.
- Responsible for the effective assessment and ongoing monitoring of prospective and approved suppliers.
- Represents the site SQM process as needed with both internal and external auditors. Ensure that users of Supplier Management and Auditing functions are trained.
- Ensures appropriate and effective SQM training for contributing site employees.
- Ensures SQM documentation is properly maintained and compliant with good documentation practices.
- Ensures that all Corrective Action / Preventive Actions (CAPA) and compliance audit corrective actions within the responsibility of the incumbent are completed on time and are effective.
- Manages the site’s Supplier Quality Improvement Team (SQIT) and is a key member to the site’s Material Review Board (MRB).
- Ensures Supplier Corrective Action Requests (SCAR) are executed per procedure, monitored/ trended as required, and closed as effective in a timely manner.
- Aligns with the Quality Monitoring team to ensure adequate statistical controls are established and maintained.
- Provides executive communication on the SQM program by means of metric review and communication.
- Supports the Management of Quality Monitoring and Trending as required.
- Provide leadership, coaching and development plans for all direct reports to maintain an engaged and productive workforce.
- Follows processes and operational policies in selecting methods and techniques for obtaining solutions. Interprets and recommends change to policies and establishes procedures that effect immediate organizations.
- Frequently interacts with subordinate supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers.
- Provide technical guidance.
- Assist with various projects as assigned.
- Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Approximately 30% travel may be required.
May be responsible for the direct supervision of various levels of Supplier Quality staff.
Bachelor’s Degree required; Advanced Degree desirable
EXPERIENCE AND REQUIRED SKILLS:
- 6 – 8 years’ related experience.
- 3+ years’ supervisory or project/program management experience preferred.
- Strong working knowledge of FDA 21 CFR 820, ISO 13485, and ISO 9000 requirements is required.
- Recent and significant experience in the medical device environment is required.
- Demonstrates leadership in managing change.
- Strong oral and written communication skills.
- Effective analytical and problem solving skills.
- Excellent attention to detail, resourcefulness, self-reliance, and confidence.
- Good working skills with Microsoft Office Suite applications are required.
- Experience with SAP is a plus.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity