GENERAL ACCOUNTABILITY:
This position reports to ITW Medical’s Director, Quality Assurance& Regulatory and is responsible for Quality Assurance activities associated with the assigned location(s). The individual will be responsible for compliance/certifications, complaints/corrective actions, and for the financial aspect of the quality function specifically tied to ownership of scrap and non-value-add activity reduction. This individual will champion the use of the Divisional Quality Management System, drive a culture change away from quality control and towards quality assurance, leverage analytics and strategic decision making to drive continuous improvement, and lead a team of quality professionals and inspectors. This position will be responsible for the quality function at the assigned manufacturing location and for quality communication for key customers of those sites, and the division.
DUTIES AND RESPONSIBILITIES:
Customer-Facing Metrics (CFM) – Drive actions to improve performance to CFMs
- On-Time Delivery – Ensure management of processes to help improve compliance to customer requested delivery dates and investigation of late deliveries to promote improvement.
- Complaint Response Time – Works with Quality Team, Peers, and other Team Members to ensure complaints are properly investigated, acted upon and responded to in a timely manner.
- Complaint PPM – Works with the Plant Management Team and other Team Members to reduce systematic contributors to defects and to ensure appropriate detection practices are implemented.
- Scrap – Drives improvement in and motivates team member engagement to identify effective solutions for scrap reduction.
- Maintain the FDA QSR / ISO 13485 – compliant Quality Management System, including assignment of primary contacts and coordinating training support. Ensure 100% alignment with Divisional Standards.
- Ensure Management Reviews are conducted to provide for systems review.
- Manage Internal Audit Program.
- Oversee management of validation activities
- Ensure appropriate protocols are written, identified actions are completed, and overall Validation reports are written.
- Management of Implementation and Documentation of IQ, OQ, PQ
- Ensure timely and conclusive validations, including validation reports.
- Participate in Design Reviews, including Technical Reviews, Feasibility Discussion, and Failure Modes and Effects Analysis (FMEA).
- Assist in documenting development work including supporting writing specifications for manufacturing or identifying and/or evaluating scientific test results.
- Act as direct contact (where appropriate) or manage contact (through Quality Engineers) for customer quality-related issues; coordinate course of action for alleviating and resolving concerns and providing timely responses.
- Identify corrective/preventive actions for continuous improvement (effectively implemented and closed in a timely manner) and quality improvement as needed for Production and Business Unit Goals.
- Ensure completion of necessary paperwork such as Complaints, CAPA, Alerts, and other relevant documents.
- Ensure Root Cause Analyses are conducted to establish reasons and solutions for Quality issues.
- Maintain product supply with minimum Scrap and NVA activities.
- Drive improvement by using data-based information to drive Scrap Reduction, elimination of NVA activities, and On-Time Delivery improvements
- Use charts/graphs/data to lead/support scheduled meetings.
- Review Batch Release and DHR compilation, with a view to automating and reducing time for completion
- Offer input for areas of improvement in products, processes, and procedures.
- Provides partnership with our First Team to champion employee engagement efforts.
- Manages talent acquisition and develops new hire onboarding plans as needed.
- Provides frequent performance feedback and completes annual reviews for the team.
- Guides the Quality team to manage daily production activities with minimal direct supervision.
Position Skills and Experience Requirements:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Bachelor’s Degree Business Administration, Engineering or related field required; certification to internal auditing preferred.
- 5-7 years Quality Management experience, preferably in medical devices required.
- Strong Analytical ability utilizing Statistical Techniques (AQL/RQL, CPK, GR, DOE
- Experience driving zero PPM in a lean manufacturing environment.
- Knowledge/experience with ISO 13485 and 21 CFR 820, or equivalent; quality system requirements required.
- Ability to use MS Office Tools such as Word, Excel, Project (or other project management software), Access and MiniTab® (or other statistics software).
- Ability to build respect/trust within internal staff/other functional leaders as well as external customers.
- Excellent interpersonal, communication (verbal and non-verbal), and presentation skills.
- Possesses excellent time management, prioritization abilities, and strong project management skills.
- Highly motivated, detail-oriented, and eager to drive needed change.
- Demonstrated ability to autonomously make strategic decisions.
- Must possess comprehension and reasoning skills used to understand and collect data, interpret technical instructions, and draw valid conclusions.
- Ability to travel occasionally to other ITW locations and for customer visits.
As an equal employment opportunity employer, ITW is committed to equal employment opportunity and fair treatment for employees, beginning with the hiring process and continuing through all aspects of the employment relationship.
All qualified applicants will receive consideration for employment without regard to race, color, sex, gender identity, sexual orientation, religion, national origin, age, disability, protected Veteran status or any other characteristic protected by applicable federal, state, or local laws.