Senior Quality Technologist - Sterility

Overview

Performs or manages testing of various products to assist Quality, Production, Research and Development, and Marketing in their integrated goal of product improvement through detailed investigation and data collection and participates in problem-solving or process improvement projects to assist Contec, Inc. in achieving its business objectives. Supports corporate quality improvement efforts. Assists in coordinating and supporting quality assurance / control programs. Assures continuous production of products consistent with established standards by performing or supporting the following duties :

Responsibilities

• Responsible for all aspects of the sterile validation of products from development through full manufacturing, including testing, monitoring, changes, investigations, and compiling customer validation packets. Serves as a resource for the sales and technical teams for all sterile products. Provides letters as needed to customers regarding shelf life, stability, and sterilization.
• Supports quality objectives to maximize product performance, improve customer experience, and minimize costs.
• Supports the quality team through lab equipment knowledge and expertise, including industry standards (such as IEST, AAMI, PDA, and ISO,). Knowledgeable in applicable product test methods.
• Serves as the primary point of contact with sterilization facilities for audits, nonconformances, dose mapping, trials, etc.
• Manages external laboratory testing, and assists Quality Manager in budget planning.
• Supports the CAPA process.
• Helps ensure complete and thorough investigation of customer complaints and / or supplier-related complaints, including determination of root cause, containment actions and appropriate corrective actions to prevent recurrence.
• Communicates to customers and suppliers on quality related issues.
• Participates in customer, supplier, and ISO audits and aids in company responses before, during, and after audits.
• Supports the internal audit process and assists in periodic quality audits.
• Supports training activities related to product quality.
• Assists in developing Work Instructions, Management Procedures, and Test Methods. Conducts periodic reviews and ensures quality procedures are maintained.
• Maintains company product quality standards in accordance with Contec's quality goals.
• Participates in continuous improvement process as applicable to primary job responsibilities.
• Helps review development documentation (Drawings and Specifications) and product test data that will be used to develop product data sheets.
• Participates and works within ISO 9001 quality standards guidelines in accordance with Contec's quality goals.

OTHER DUTIES AND RESPONSIBILITIES that may apply as deemed necessary in this role :

Others may be assigned.

Competencies

Problem Solving : Making sense of complex, high quantity, and sometimes contradictory information to effectively solve problems.

Decision Making : Making good and timely decisions that keep the organization moving forward.

Communicates & Listens Effectively : Developing and delivering multi-mode communications that convey a clear understanding of the unique needs of different audiences. Listens to accurately receive and interpret messages in the communication process.

Action-Oriented : Taking on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm.

Supports Core Values : Able to demonstrate support and adherence to Contec's core values : respect for others, doing "whatever it takes" within Contec's core values, vision, and strategic direction, exhibiting integrity, having a tolerance for risk, understanding there is life outside of work, enjoying the ride.

Qualifications / Requirements

Bachelor's degree (B.S.) from four-year college or university in a field in the science or similar major, or three to five years of related experience; or an equivalent combination of education and experience.

Physical Demands

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the associate is regularly required to remain in a stationary position, typically at a desk; occasionally required to remain in a stationary position on concrete manufacturing floor; regularly required to move between office locations and manufacturing floor; regularly operate a phone, computer, printer, and copier; occasionally position self to view or retrieve products from various levels. The associate will constantly communicate with peers, customers, and other departments through both verbal and electronic communication such as email; must be able to convey shop order or project status and exchange accurate information in these situations. Must be able to read small product labels, product drawings, and other documents. Must be able to assess a product for damage or defects. The associate is occasionally required to lift and / or move up to 50lbs with assistance. Steel toed shoes will occasionally be required in the manufacturing area. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those that an associate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the associate will generally spend 50 - 70% of the time in an air-conditioned, quiet office environment. The remaining time will be spent in a higher temperature, moderately noisy manufacturing environment with forklifts, pallet jacks, and other manufacturing equipment with moving parts. Hazardous chemicals are regularly used in the manufacturing environment, and the associate will be occasionally exposed to these chemicals.

The associate will occasionally be required to enter the Cleanroom and must be able to tolerate periods of time in full cleanroom garments (ex., suit, hood, boots, masks, gloves, etc.).