Quality Engineer

Job Description

Job DescriptionBenefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off

Quality Engineer

COMPANY OVERVIEW:

Sage Product Development, Inc. provides fast, efficient and creative product development and manufacturing services to medical device companies. We are a focused team of experienced medical device engineers who know what it takes to develop successful products for startups, multinational companies, and everyone in between.

We combine a high level of experience with a low overhead company structure. We are all about solving client companies technical challenges and meeting their product development needs in a timely, efficient and highly personalized manner.

We offer the right candidate the opportunity to work in an entrepreneurial environment, enhance their quality engineering abilities, and build their network within the industry.

GENERAL SUMMARY:

• Ensure the companys continued compliance with relevant quality standards.
• Play a key role in establishing and maintaining low-volume medical device manufacturing capabilities at Sage.
• Contribute to the success of product development projects by providing quality engineering expertise.

ESSENTIAL JOB FUNCTIONS (all as required by client companies):

Quality Systems:

• Develop and maintain quality assurance procedures and controls to ensure that company operations meet established standards and agency guidelines, with a priority on efficiency and simplicity.
• Assure that the companys quality management system is in ongoing compliance with applicable standards and regulations, including ISO 13485:2016 and 21 CFR part 820.
• Manage the companys Internal Audit process. Coordinate the activities of outside consultants who provide Internal Audit services. Ensure that appropriate actions are taken as a result of Internal Audits.
• Approve Document Change Orders (DCOs) and obtain approvals from others as required.
• Manage the companys Calibration and Preventive Maintenance system.
• Manage the companys Complaints system.
• Manage the companys CAPA system.
• Manage the companys Training system.
• Manage the companys NCMR and Process Deviations system.
• Perform Pest Control monitoring.
• Identify, analyze and implement improvements to both manufacturing and design processes.

Manufacturing:

• Provide Quality oversight in the manufacturing process. Review and approve manufacturing documentation such as routings, inspection reports, NCMRs, etc.
• Manage the companys Supplier Management system. Ensure that suppliers are qualified as required. Develop, implement and manage processes for tracking supplier performance.
• Perform component, assembly and finished-goods inspection. Identify, procure and maintain required inspection equipment. Perform and document component, assembly and finished-goods inspection.
• Manage the companys NCMR system. Participate in NCMR disposition determination and documentation. Make decisions regarding product and material discrepancies and initiate appropriate action to prevent subsequent problems or discrepancies.
• Maintain the cleanroom. Ensure ongoing cleanroom environment monitoring, microbial monitoring, and annual certification.
• Maintain processes to ensure that device packaging and labeling meet regulatory requirements and customers needs. Inspect labels.
• Manage the sterilization of devices by outside vendors. Conduct and document sterilization validations.

Product Development:

• Provide quality engineering expertise in projects to develop medical devices (disposable and reusable), catheters, equipment, implants, and/or packaging. Ensure that products meet performance specifications, regulatory and manufacturing requirements.
• Provide Quality Engineering services to client companies.
• Interact with client companies in a professional manner. Proactively communicate with client companies to ensure an ongoing two-way exchange of information.
• Participate in product verification and validation testing and data analysis.
• Conduct or contribute to risk analyses, including Failure Mode and Effects Analyses, Hazard Analysis, and Risk Management Plans and Reports.
• Contribute to other project documentation, such as Design Input, Verification and Validation plans, protocols and repor

Occasional local travel (i.e. by car). Occasional long-distance travel (i.e. by plane).

OTHER DUTIES AND RESPONSIBILITIES

• Any other duties as assigned.

REQUIRED COMPETENCIES

Customer Focus

• Provide professional, reliable and prompt service to client companies and coworkers. Work in partnership with others to meet or exceed customer expectations. Interpret customers needs and take appropriate action. Follow through on customers inquiries in a professional and timely manner.

Management of Resources

• Work in an organized and time effective manner. Proactively seek out relevant reference materials as necessary. Take initiative for self-development. Prioritize tasks effectively. Demonstrate initiative and innovation in the use of available resources.

Communication Skills

• Write and speak in a concise, technically accurate, timely, and professional manner. Exhibit strong verbal presentation and negotiation skills. Interact with client company personnel in a positive and professional manner. Express ideas, recommendations, and solutions clearly, logically, and concisely in both written and verbal communications. Demonstrate tact and diplomacy in communications. Demonstrate active listening skills and ability to resolve discrepancies with customers.

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES:

• Bachelor's degree in Engineering or relevant science is required. Masters degree in engineering, management or business is a plus.
• One or more years of medical device quality engineering experience is required.
• Commitment to satisfying quality and regulatory requirements in a way that maintains and promotes efficiency of operation is required.
• Ability to interact with client companies in a professional manner.
• Knowledge of probability and statistics.
• Proficiency with commonly used computer software such as Excel, Word, PowerPoint, etc.
• Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.

SUPERVISORY RESPONSIBILITY:

• May direct the work of other people, and may have direct reports.

REPORTS TO:
Director of Quality

WORKING CONDITIONS/PHYSICAL DEMANDS:

• Must be able to move throughout office and laboratory space, using a complete variety of office equipment and laboratory machinery and tools. Must be able to lift more than 50 pounds and stand for extended periods of time. Must tolerate exposure to chemicals found in a laboratory environment.
• The above statements are intended to describe the general nature and level of work being performed by people assigned to do this job. The above is not intended to be an exhaustive list of all responsibilities and duties required.
• External and internal applicants, as well as position incumbents who become disabled as defined under the Americans with Disabilities Act must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by management on a case by case basis.