Manufacturing Quality Engineer

Description

POSITION DESCRIPTION

Position Title: Manufacturing Quality Engineer

Reports To: Head of Quality

Department: Quality Assurance

FLSA Status: Exempt

Scope of Role: Individual Contributor

Version Date: 2023.07.06

Job Code: ManufQualEng

Job Grade: TBD

PURPOSE OF POSITION

The Manufacturing Quality Engineer is primarily responsible for providing quality guidance to Operations, Manufacturing and Supply Chain, and will support manufacturing transfer activities of existing and new medical products in accordance with applicable regulatory requirements and operational procedures. Secondarily, the position is responsible for supporting, as directed, the company’s quality systems in place to ensure compliance with all applicable regulatory requirements and standards.  

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

As directed:

• Reviews and approves quality records for finished medical device release, ensuring that the finished product meets acceptance requirements as defined in the Device Master Record.
• Review and approve logs, preventative maintenance reports, scrap tickets, software updates, labels, and other documentation.
• Partner with operations to perform process risk management activities including hazard identification, hazard analysis, FMEA, and risk mitigation consistent with ISO 14971.
• Lead and execute IQ, OQ, PQ activities to validate manufacturing processes for medical device products.
• Perform root cause analysis on non-conformance issues and implement corrective and preventive actions following CAPA procedures.
• Perform ISO 13485 or ISO 9001 external supplier audits and ensure adherence to supplier quality agreements.
• Work closely with the Operations teams to transfer design changes into manufacturing.
• Initiate, review, and approve Engineering and Manufacturing Change Orders.
• Support non-conforming root cause analysis and resolution of operations related issues.
• Provide data for quality metrics, as required to support Management Reviews.
• Serve as Quality SME on cross function teams. 
• Participate in ongoing issue tracking and trending meetings such as Change Review Board and CAPA Board. 
• Conduct training on procedures.
• Quality support for qualification of new suppliers, resolution of supplier change notifications and supplier corrective actions. 
• Develop and maintain quality systems, including standard operating procedures, work instructions, and forms.
• Serve as Quality SME and work with staff to answer common Quality inquiries or aid in addressing internal and external audits from regulatory agencies.
• Collaborate with site leadership to ensure manufacturing quality needs are fully understood and prioritized by providing management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion.
• Review process control charts for manufactured products that are maintained by operations/production for each product type and review the upper and lower control limits which shall be within the specification ranges for the product type.

Requirements

KEY COMPETENCIES

• Knowledge of ISO 13485:2016 and 21 CRF Part 820.
• Must have a “hands-on” approach and work effectively on cross-functional teams to establish and maintain appropriate processes pertaining to Quality.
• Excellent attention to detail, well organized and able to work independently and with a team.
• Strong organizational and time management skills and excellent written and oral communication skills.
• Working knowledge of: CAPA, non-conforming product investigations, deviations, change control, training and document control, complaint investigation, field actions and risk assessments, as it relates to batch record release.
• Proficiency on a PC and experience with Microsoft Office Products.

EDUCATION & EXPERIENCE REQUIREMENTS

• Minimum 2 years’ experience in quality engineering role in the medical device industry required.
• BA/BS degree in science, engineering or related technical field; or equivalent combination of skills and experience.
• Experience participating in and leading internal and external audits (e.g., FDA, Notified Body, Supplier) preferred.
• Familiar with working in a manufacturing and product design environment preferred. 
• Experience in in vitro medical diagnostics industry preferred.
• Experience interacting with Notified Body audits and FDA, including presenting information to the auditor and preparation of requested information in a timely manner requested by the auditor preferred.

PHYSICAL AND COGNITIVE DEMANDS

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

• This position is primarily based out of the company Headquarters in Durham, NC 
• This position may involve travel as needed, up to 10%.

While performing the duties of this job, the employee is regularly required to:

• Listen and communicate using both verbal and written feedback. Must be able to exchange accurate information in these situations.
• Maintain a high level of consistent cognitive function.
• Perform consistent keyboarding/computer use in a typical office environment for extended periods of time, up to 8 hours per day.
• Frequently move about the office.
• Stoop, kneel or crouch when maneuvering the office environment.
• Perform work in manufacturing and/or research laboratory environments as needed, up to 8 hours per day.
• Lift up 50lbs at times. 
• Be fully vaccinated against Covid-19 or meet the requirements for a medical or religious exemption.

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions and perform any other duties, as assigned by their manager.