Job description
general objective:
this position is responsible for providing leadership and is assigned the authority to implement, coordinate, and monitor the facility’s quality system. Acts as the sterilization facility’s quality representative, iso management representative, and lead quality system contact for all activities related to the facility as directed by the director of sterility assurance, with a commitment to quality, accuracy, and process improvement.
responsibilities:
organization, planning, and control
* represent the facility on all quality matters pertinent to the quality management system, in accordance with customer, regulatory, and organizational policies.
* implement and communicate new or revised quality system and regulatory compliance policies and procedures.
* ensure adherence to qsr and iso regulations; maintain knowledge of relevant regulations and establish monitoring programs to respond to audits.
* ensure processing records comply with specifications and regulatory requirements before product release. Has authority to withhold release of non-conforming products and escalate issues appropriately.
* maintain current customer processing specifications accessible to staff.
* review operations, calibration, and maintenance records to ensure process control and good documentation practices. Oversee calibration and qualification documentation.
* monitor sample transmittal for validations and routine processing.
* collaborate with management to identify root causes of deviations and implement corrective actions. Oversee training programs related to procedural and policy changes.
* represent the facility during customer and regulatory audits, providing leadership and ensuring corrective actions are documented and effective.
* coordinate validation protocols and reports, and oversee the supplier/vendor program.
* report on quality system trends and data, recommend improvements, and communicate quality reports regularly.
* lead and mentor sterilization engineers/specialists to ensure performance and professional growth.
* support a safe, clean, and secure work environment, participating in safety committees and protecting confidential information.
* participate in internal audits and oversee the maintenance of quality documents and records.
* maintain daily quality system operations with a focus on continuous improvement and cost efficiency.
* make technical decisions regarding sterilization practices and standards.
* resolve customer complaints, audit findings, and quality concerns.
academic and experience requirements:
* minimum of 5 years' experience in medical device manufacturing, pharmaceuticals, sterilization operations, and quality system fda regulations (qsr), with preference for validation experience.
* knowledge of iso 13485:2016, aami sterilization methods, iso 11135, and statistical techniques such as spc and experimental design.
* at least 2 years of supervisory or management experience.
* proficiency in microsoft word, excel, and powerpoint.
* lean six sigma black belt certification is preferred.
soft skills:
* ability to work independently and make risk-based decisions.
* adaptability to changing duties and responsibilities.
* influence and negotiate effectively.
* strong organizational, leadership, and conflict management skills.
* effective interpersonal skills and self-motivation.
educational qualifications:
* bsc in a scientific or engineering field, or equivalent industry experience.
* master's degree preferred.
medline industries, lp is an equal opportunity employer, evaluating qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability, or any other protected characteristic.
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