Quality Engineer - Military veterans preferred

POSITION SUMMARY:
Responsible for implementation of Quality Systems elements in accordance with FDA Quality Systems Regulations and ISO 13485 standards. Responsible for providing direct support and oversight of product and manufacturing engineering activities including manufacturing process capability and supply chain quality management.

PRINCIPAL JOB DUTIES & RESPONSIBILITIES:
• Perform as an active member of product design and development teams, participating in project meetings, design reviews, risk management, and other activities as required by the Design Control Process.
• Participates on Build-4-Me Product Development and Manufacturing team to assure that all quality and regulatory issues are addressed for customer requested modification.
• Provides Quality review and authorization for documentation changes to engineering prints, project Quality Plans, manufacturing work instructions, process sheets and inspection plans.
• Provides Quality review for product design changes. Carry out process validations, equipment qualifications and assist with material certification as necessary from the suppliers.
• Execute and administer CAPA (Corrective and Preventive Action) tools as required, both internally and externally to bring about the desired positive changes and continuous improvements.
• Assist in defining/maintaining Quality metrics for internal and external reporting. Perform trend analysis as required.
• Review Design History Files for accuracy and compliance to internal and FDA requirements.
• Revise Quality System and Manufacturing procedures as required.
• Represent Quality on various teams and projects, including supporting ISO or FDA Audits/Inspections providing data analysis as needed.
• Initiate and investigate NCMR’s, initiate Deviations when required and participate in control of non-conforming materials.
• Assist on product improvement projects, supplier first article inspections and supporting supplier technical audits.
• Other special projects/assignments as designated by the Quality Manager.

REQUIRED SKILLS, KNOWLEDGE AND EXPERIENCE:
• Bachelor of Science in an engineering discipline or equivalent experience. Mechanical, Manufacturing, Process or Quality Engineering Degree a plus.
• Two years of experience in manufacturing or quality environment required. Medical devices equipment and/ or wheelchair/mobility products experience a strong plus.
• Knowledge of computer database systems, Microsoft applications, PC, and various software programs required.
• Strong aptitude for problem solving, root cause analyses, and an understanding of dynamic mechanical assemblies desired. Process/product validation and design control experience a plus.
• Knowledge of ISO 13485, 21 CFR 820, and ISO 14971 preferred.
• Certified Six Sigma Green Belt Certification a plus.
• Experience with Quality Risk Assessment tools such as FMEA, MRB, CAPA, required.
• Capable to present data (presentations) to management teams and train co-workers as needed.
• Must have ability to properly interpret Engineering drawings and clearly present that information to others.
• Ability to travel to other facilities and/or suppliers to support quality audits and/or issues is required.

COMPETENCIES:
• Analytical Thinking – Approaching a problem by using a logical, systematic, sequential approach.
• Building Collaborative Relationships – Developing and maintaining partnerships with others.
• Diagnostic Information Gathering – Identifying the information needed to clarify a situation, seeking that information from appropriate sources, and using skillful questioning to draw out the information.
• Forward Thinking – Anticipating the implications and consequences of situations and taking appropriate action to be prepared for possible contingencies.
• Fostering Teamwork – As a team member, the ability and desire to work cooperatively with others on a team; as a team leader, interest, skill, and success in getting groups to learn to work together cooperatively.
• Influence Skill – Gaining others’ support for ideas, proposals, projects, and solutions.
• Initiative – Identifying what needs to be done and doing it before being asked to or required by the situation.
• Oral Communications – Expressing oneself clearly in conversations and interactions with others.
• Personal Credibility – Demonstrated concern that one be perceived as responsible, reliable and trustworthy.
• Persuasive Communication – Planning and delivering oral and written communications that are impactful and persuasive with their intended audiences.
• Providing Motivational Support – Enhancing others’ commitment to their work.
• Results Orientation – Focusing on the desired end result of one’s own or one’s unit’s work; setting challenging goals, focusing effort on the goals, and meeting or exceeding them.
• Self Confidence – Faith in one’s own ideas and ability to be successful; taking an independent position in the face of opposition.
• Written Communication – Expressing oneself clearly in business writing.

PHYSICAL REQUIREMENTS:

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.
• Deductive Reasoning — The ability to apply general rules to specific problems to produce answers that make sense.
• Fluency of Ideas — The ability to come up with a number of ideas about a topic.
• Inductive Reasoning — The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
• Information Ordering — The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations).
• Lifting/ Carry Weight - Must frequently move and lift up to 10 lbs. and occasionally lift and/or move up to 40 lbs.
• Mathematical Reasoning — The ability to choose the right mathematical methods or formulas to solve a problem.
• Oral Comprehension — The ability to listen to and understand information and ideas presented through spoken words and sentences.
• Oral Expression — The ability to communicate information and ideas in speaking so others will understand.
• Problem Sensitivity — The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem.
• Selective Attention — The ability to concentrate on a task over a period of time without being distracted.
• Speech Clarity — The ability to speak clearly so others can understand you.
• Speech Recognition — The ability to identify and understand the speech of another person.
• Written Comprehension — The ability to read and understand information and ideas presented in writing.
• Written Expression — The ability to communicate information and ideas in writing so others will understand.