KEY RESPONSIBILITIES Responsible for the development and deployment of a quality systems and compliance strategy, (including document control) that is harmonized to both global and local objectives. The primary responsibilities include working on strategies to sustain and enhance our quality systems, in conjunction with the Quality Systems group, translating strategies into measurable goals and objectives for the quality systems group and the implementation of those initiatives. This position will be the primary interface between quality systems and quality engineering and quality control, and will also work closely with other business groups including Global QM/RA, manufacturing services, operations and supply chain. The main purpose of the quality systems function is to ensure compliance of our quality systems and to continually improving the Quality and Environmental Management Systems and our systems, products and processes.
The Senior Manager Quality will:
· If defined on the Organizational Chart to Act as Alternate Management Representative in the absence of the Management Representative for the Quality System as defined in 21 CFR Part 82O, Subpart B 820.20b(3).
· Ensure that processes needed for the quality management system are established, implemented and maintained.
· Report performance of the quality management system, including any need for improvement, to Executive Management.
· Ensure the promotion of awareness of regulatory and customer requirements throughout the organization.
· Coordinate all activities relative to obtaining desired certifications for operations, e.g., ISO 13485, ISO 9001 and ISO 14001 registration in the absence of the Management Representative. Act as the alternate ISO Management Representative, as required
· Responsible for the management of key elements of the Quality Management System, including CAPA, Complaint Handling and Audits.
· Responsible for the management of the quality systems staff.
· Responsible for establishing the strategy for the quality systems program and for representing the company on any regional or global harmonization efforts.
· Responsible for establishing goals and objectives and projects for the quality systems team and for coordinating efforts with the quality engineering staff, as applicable.
· Lead/participate in the supplier leadership efforts in conjunction with the supply chain/materials team, focused on key supplier development based on current and historical metrics such as quality and on-time delivery.
· Analyze and respond to CAPA thresholds and work with the various cross-functional teams to resolve issues.
· Provide training and lead supplier audits, when necessary.
· Function as department supervisor on occasion of the Director’s absence.
· Support lean manufacturing and continuous improvement efforts, including in-sourcing projects, waste reduction efforts, inventory reduction efforts, etc.
· Evaluate changes in products per organizational risk management practices to ensure effective, safe and complaint devices are released to the market in accordance with current state and federal standards.
Oversight of team that performs the following functions (should be knowledgeable in all areas):
· Internal Audits (planning, training, scheduling, conducting)
· Coordination of 3rd Party Audits (planning, communication, issuance of findings, follow-up for effectiveness)
· Coordination of Supplier Audits (planning, training, scheduling with QE’s, conducting, issuing findings, following-up for effectiveness)
· Supplier Leadership Team Standard Work (Data review/analysis for supplier risk levels, RIS completion, quarterly scorecard communication verification, probationary/new supplier status, expiring ISO Certificates)
· Corrective and Preventive Action System; As issues identified (via audits, internal notification, incidents, supplier issue, etc.) document the finding/incident, issue formal reports, document responses, follow-up on action completion and effectiveness, maintain systems/logs
· Warranty Review Data (log maintenance, trending/analysis, recommended actions to the business)
· Complaint Handling Data (log maintenance, trending/analysis, recommended actions to the business)
· Inter-Site Return Process and Data (log maintenance, trending/analysis, recommended actions to the business)
· Non-Conforming Material Report Data (log maintenance, trending/analysis, recommended actions to the business, issuance of SCARs for supplier caused trends)
· Management Review Data (Excel spreadsheet maintenance, end of year archiving and file reset, overall analytical input for VICP, file review and follow-up on incomplete, inaccurate information.)
· Oversight of RIS (Request for Initial Samples) Process and Data (trending/analysis, ensuring new components make it through the process when required)
PROFESSIONAL EXPERIENCE/QUALIFICATIONS · B.S. Degree in a Technical/Engineering discipline required. MBA or advanced degree preferred.
· 10 years minimum experience in quality assurance, quality systems, and engineering change management (document control) in a medical device manufacturing company. Must include at least 2+ years in a management Quality role.
· Proven history in managing FDA inspections and ISO Audits.
· Advanced knowledge of FDA QSR, ISO 13485, ISO 9001 and ISO 14001, including practical application of these standards is required.
· Auditing experience to FDA QSR and ISO standards required. RAB certification preferred.
· Strong basic statistics experience, including statistical process control.
· Conversant with software applications for Microsoft Windows including Excel, PowerPoint and Word. SAP experience preferred.
· Strong project management skills, analytical and organizational skills required.
· Ability to communicate effectively with personnel at all levels both verbally and in writing.
· Able to communication effectively outside of the organization and to participate on and possibly lead global initiatives.
· A self-starter able to function independently with minimum direction and to act on behalf of the Director of Quality Assurance in his/her absence.
· Travel up to 30% possible.
· Knowledge of Process validation, IQ, OQ, PQ, inspection plan development, process control plans, and DFMEA/PFMEA’s required.
· Experience using statistically based sampling plans.
· Knowledge of blue print reading and basic measurement techniques.