My client is looking for a Quality Engineer with medical device experience. The incumbent will assist in the design and implementation of policies and procedures to ensure quality standards are met during production, that company products meet customer expectations and achieve superior reliability while maintaining compliance with Federal, State and other regulations and standards governing the medical device industry, including but not limited to FDA, ISO, UL, OSHA, EPA, ASTM, ANSI. Assist in the development of quality standards and protocols for quality assurance testing models. Designs and implements policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
Analyze statistical data and product specifications to determine standards and establish quality and reliability objectives of finished product.
Plan and establish sequence of operations to fabricate and assemble parts or products and to promote efficient utilization.
Coordinate quality control objectives and activities to resolve production problems, maximize product reliability and minimize cost.
Confer with vendors, staff and management personnel regarding purchases, procedures, product specifications, manufacturing capabilities, and project status.
Review production schedules, engineering specifications, orders, and related information to obtain knowledge of manufacturing methods, procedures and activities.
Communicate with management and user personnel to develop production and design standards.
Conducts research to evaluate safety levels for products.
Advises and recommends procedures for detection, prevention, and elimination of physical, chemical, or other product hazards.
Participates in product usage and precautionary label instructions.
Prepares reports of findings from investigation of accidents.
Investigates causes of accidents, injuries, or illnesses from product usage to develop solutions to minimize or prevent recurrence.
Evaluates potential health hazards or damage which could occur from misuse of product and engineers solutions to improve safety.
This job has no supervisory responsibilities.
Competencies: To perform the job successfully, an individual should demonstrate the following competencies:
Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
Demonstrates attention to detail.
Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities.
Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
Responds to requests for service and assistance; Meets commitments.
Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
Understands business implications of decisions; Aligns work with strategic goals.
Conserves organizational resources.
Shows respect and sensitivity for cultural differences.
Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Supports affirmative action and respects diversity.
Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Completes work in timely manner.
Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience
Bachelor's degree from accredited college or university; with 5 – 7 years related experience; or equivalent combination of education and experience.
Experience in visual and functional quality inspection.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
Certificates, Licenses, Registrations
ASQC CQE preferred.
Work Schedule/Hours, Travel
,Regular work hours are Monday thru Friday, 8:00 a.m. - 5:00 p.m.
Occasional work outside of regular business hours may be required.
Minimal overnight travel, by land and/or air may be required.
No visa sponsorship (H1-B, etc.) available at this time, sorry.