Department	Quality Systems	Manage Employees	No
Reports to	Sr. Quality Management Director	FLSA	Non-Exempt

Summary (Main Purpose)

The Sr. Quality Engineering Technician assures the consistent quality of production by helping develop and enforce good manufacturing practices, validating processes, gathering data, and providing documentation. The Sr. QET will maintain quality engineering methodologies and provide quality technical support within the new product. Be the lead in reviewing, writing, and implementing quality documents and training. This position is highly document control related along with applying problem-solving skills.

Job Duties and Responsibilities (Essential Functions)

• This is a hands-on position that will support day to day needs of quality assurance and systems within the manufacturing facilities in order to support the needs of and prevent escapes to the customer.
• Support and serve as a resource for the quality issues including but not limited to nonconformance failure investigations, assisting in establishing scope or extent of non-conformance failure investigations, assisting in establishing scope or extent of non-conformances assist in determination/completion of risk assessment and rework activities.
• Data entry of NCRs, CAPAs, complaints, and more into Lowell’s QMS software. Manage the company’s QMS system. Maintain the Quality system KPIs and support the Quality Objectives Meeting (QOM) reporting.
• Works closely with the quality management to the business-related activities to ensure adequate operational support.
• QC Tools – Assist Quality Assurance and Manufacturing with process Control Plans and FMEA’s as directed
  Root Cause / Corrective Action (RC/CA)– Collaborate with the Manufacturing team and Quality to understand the root cause for defects and process-related concerns and identify both short- and long-term corrective actions with the ultimate goal being error-proofing.
• The position requires an understanding of Structured Problem Solving and Quality Management System (and the culture that accompanies it) as well as the motivation to continuously improve these systems and practices as well as the ability to balance priorities, drive accountability and action and communicate in a detailed and real-time manner.
• Supplier – As needed, facilitate engagement with suppliers to identify RC/CA in a timely and robust manner.
• Audits – Support audits (both internal and external) and audit follow-up as needed.
• Works with human resources to ensure training is completed and competency is adequate.
  Interactions and support will be primarily limited to the internal manufacturing team and engineers, although, there may be some follow-up with suppliers or customers as directed by Manufacturing Engineers or Quality Managers.
• Inspection methods – Work with manufacturing teams and Quality Managers to ensure the effectiveness of the methods used to identify defects and problems within the process and identify opportunities to optimize and improve.
• Communication – Keep relevant personnel informed of important developments, potential problems, and related information necessary for effective management of customer product.
• May maintain graphs and records as needed.
• Analysis – Follow up as directed on trends or anomalies identified in reporting, data and metrics.
• Escalate deviations from standard or lack of a standard to appropriate personnel for resolution.
  Supports Operation functions, Quality, Engineering, and others as needed, in the implementation of corrections/corrective actions for identified issues, through the use of quality principles and data.
• Support the MRB Team in the disposition of material and monitoring the MRB quarantine area.
• Works in conjunction with the Quality Engineering Technician to maintain the QMS.
• Completes records of acceptance, rejection, and disposition of material.
• Support or execute statistical analysis, as needed, including but not limited to FMEA and other risk management principles.
• Gain certifications that will enhance your skill level and benefit you and the company as a whole.
• Gain experience and training to go to the next step, a certified Quality Engineer.
• Performs related work as apparent or assigned.

Required Skills and Experience (Minimum requirements in terms of educational background, work experience, licenses/certifications, or other knowledge, skills, and abilities).

• Proficient with Excel, PowerPoint, Minitab, and Word.
• Provide communication in a simple and logical way (Presentations, Charts, etc.)
• If not already, be willing to obtain a Bachelor’s of Science in mechanical or a quality-related degree, starting within 12 months of hire with tuition assistance.
• Obtain and maintain American Society for Quality certificates: i.e., Certified Quality Auditor, Certified Quality Improvement Associate, Certified Quality Engineer, or Certified Medical Device Auditor.
• Two to Four years of experience within manufacturing operations, preferably in the medical device industry.
• Knowledge of product and customer specifications. Basic GD&T applications and understanding of product drawings.
• General Knowledge of medical devices preferred.
• Experience working in a regulated environment.
• Recognize and report quality deviations – perform in-process audits inspections according to written procedures accurately document results.
• Knowledge of Good Manufacturing Practices (GMPs) and ISO (International Organization for Standardization) policy and procedure.
• Assist in quality troubleshooting efforts.
• Internal audit trainer and organizer.
• FDA inspection, customer, and supplier audit support.
• This position is a precursor to a Quality System Engineer.
• Basic Computer skills and use of software applications.
• Experience training others.

Additional Skills and Experience (Preferred or helpful)

• Maintain knowledge of all procedures, change to specifications (Process, Training, Manuals, Material Specifications, et), and regulations related to their area of responsibility.
• Responsible for supporting customer, governing body, supplier audits, and inspections.
• Maintain process knowledge for the assigned area of responsibility.
• Recommends and makes the revisions to existing SOP and other QMS documentation.
• Provide initiative to make improvements to the QMS.
• Fosters collaborative discussions with Lowell associates regarding quality issues, projects, and activities as required.
• Working knowledge of FDA requirements and GMPs.
• Self-Motivated.
• Excellent attention to detail.
• Strong organizational, prioritization, multi-tasking, and planning skills.
• Flexibility to adapt and meet fluctuating schedule and priority changes.
• ERP system experience.
• Availability to Travel, when required customers or suppliers to conduct quality-related activities. 1-2 times a year.
• Manages varying circumstances and changing conditions as multiple situations may have to be addressed at the same time.
• Works in different areas of quality based on business needs.
• Support/Provide coverage for absences as required.
• Work cooperatively toward effective outcomes.
• Work to resolve differences in a collaborative effort.
• Attend training to enhance your abilities. For example, Quality Certification, Seminars, Webinars, ASQ membership and involvement, and Trade Shows.

Demands and Conditions Analysis: Sr. Quality Engineer Technician

Working Conditions

The essential functions of this job involve the following working conditions.

C = Continuously, 75%-100%
F = Frequently, 50%-74%
O = Occasionally, 10%-49%
R = Rarely, 1%-9%
N = Never, 0% of time

	C	F	O	R	N		C	F	O	R	N
Environmental						Physical Factors
Works alone		X				Sitting	X
Works with others			X			Standing			X
Customer contact				X		Walking			X
Shift Work				X		Bending/stooping				X
Extended Day			X			Squatting/Kneeling				X
Keeping work pace/deadlines				X		Crouching/Crawling					X
Performing repetitive tasks				X		Twisting at waist					X
Noise (decibels) 91					X	Reaching above shoulders					X
Vibration					X	Reaching below knees					X
Abrupt temperature changes					X	Lift/carry up to 40 lbs.					X
Heat (above 85 F)					X	Push/pull to 100 (force)					X
Cold (below 65 F)					X	Climbing ladders					X
Wetness					X	Climbing stairs					X
Dampness					X	Sweeping/mopping					X
Dryness					X	Operating foot controls					X
Odors & dusts					X	Manual Tasks
Work with solvents					X	Grasping with one hand				X
Work acids, bases					X	Grasping with both hands					X
Work with oils					X	Manipulating with one hand					X
Work with toxins					X	Manipulating with two hands					X
Poor ventilation					X	Handwritten communication			X
Fumes					X	Using keyboard	X
Mechanical hazards					X	Using hand tools					X
Electrical hazards					X	Twisting/wringing					X
Sensory Tasks						Scrubbing/washing/polishing					X
Seeing close (reading)	X					Scraping					X
Seeing far (observation)			X			Equipment Operation
Peripheral vision			X			Driving car / light truck					X
Seeing colors			X			Driving heavy truck / van					X
Verbal communication	X					Operating forklift, stackers					X
Hearing speech		X				Operating hoist equipment					X
Hearing mechanical sounds					X	Operating shop machinery					X
Sensing odors					X	Operating power tools					X
Sensing by touch					X	Operating torch					X

 

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This description covers the primary purpose and principal duties of the job. It is not designed to be a complete list of all the duties and responsibilities required of this position. Duties, responsibilities, and activities may change at any time with or without notice.