Department	Quality Assurance	Manage Employees	Yes
Reports to	VP of Operations	FLSA Status	Exempt

Summary (Main Purpose)

Provide quality support to customers, suppliers, manufacturing engineers, inspection and production personnel to ensure products and processes conform to customer and regulatory requirements. Generate and maintain metrics to identify continual improvement opportunities.

Job Duties and Responsibilities (Essential Functions)

• Collect, review, analyze and publish corrective action and non-conformance data in an effort to eliminate non-conformances.
• Develop and maintain working relationships with Engineering, Quality Systems, Inspection and Manufacturing personnel to facilitate group problem solving and cooperation.
• Understand and provide support for quality requirements as needed including, certificates of conformance, sampling inspections, first articles inspections, process approval, inspection plans, test and inspection reports, PFEMA, and control plans.
• Support the completion and maintenance of risk analysis and complaint evaluations.
• Lead the investigation to resolve customer complaints and in the prevention of product nonconformances.
  Develop reports and metrics on various aspects of product assurance function including the cost of scrap and rework operations, the accuracy of inspection, quality of outgoing product, etc. Monitor nonconforming parts through RMA and the rework process including timely disposition and closure.
• Support the auditing and evaluation process to assure conformance to established standards, specifications, and customer requirements.
• Prepare reports and make recommendations for corrective or preventative action to improvement product quality. Implement action to be taken and follow up for effectiveness to eliminate or prevent nonconformances and their causes.
• Assist with the development of inspection processes and operation instructions.
• Assist the internal audit program to measure the overall effectiveness of the quality management system.

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

• Minimum 5 years of experience in a related role and industry sector.
• Proficient reading, writing, oral communication, and comprehension in the English language.
  Knowledge of industrial math.
• Knowledge and working experience with MS Office, (Word, Excel, Power-Point, Project). Knowledge of computer integrated manufacturing software including accessing and retrieving information using the computer.
• Expertise with data and defect analysis, variance reduction, and capability analysis.
• Strong knowledge in the application of Quality Systems.
• Understanding of internal auditing methods and quality system procedures.
• Understanding of Process Failure Mode Effect Analysis and control plan.
• Working knowledge of quality at the source techniques, root cause analysis, corrective action, continuous improvement.
• Ability to interpret engineering drawings.
• Strong organizational and project management skills.
• Ability to understand quality issues and assist staff in root cause problem solving to effectively meet customer needs.
• Strong interpersonal skills and demonstrated ability to work effectively within the organization and collaborate with internal and external clients to determine requirements and eliminate any barriers that may affect the quality and delivery of the product.

Additional Skills and Experience (Preferred or helpful)

• Experience working in the Medical Device industry, specifically ISO 13485:2016 and FDA 21 CFR 820.
• ASQ Certified CCT preferred or CQE desired or willing to obtain.
• Bachelor’s degree in Engineering or related discipline.
• Familiar with ANSI/NCSL Z540-01 and ISOIEC17025 a plus.
• Experience working with M1 ERP system or similar
• Ability to work well with little supervision
• Must be a well-organized problem solver.
• Possess the ability to make rational knowledge-based decisions.

Demands and Conditions Analysis: Quality Engineer

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.