• Quality Engineer (Medical)

    Job Locations US-NC-Asheboro
    Posted Date 2 weeks ago(2 weeks ago)
    Job ID
    # of Openings
  • Overview

    The position reports to the Quality/Regulatory Affairs Manager and involves activities related to the Quality System for both existing and new product launched. The position will interface with all disciplines within the Plant and also the end customer.


    Essential Duties and Responsibilities

    • Take customer calls and/or complaints and analyze problems.
    • Inquire/question customers and determine decision. Notify plant and give them a heads up.  If the problem is serious, call upper management.
    • Identify problem, relay containment to customer and form a correction action team. Identify root cause, and undertake corrective action policy.  Write corrective action and report back to the customer.
    • Ensure corrective actions are implemented on the floor and also present corrective action in-person, to the customer.
    • Must become familiar with customer processes.
    • Revise OMI’s based on quality issues.
    • Conduct internal audits.
    • Write/revise standard operating procedures/work instructions.
    • Create templates to support quality management functions.
    • Review and disposition requests for Customer Returns of rejected materials.
    • Manage 3rd party sort activities initiated at Customer’s site.
    • Analyze data retrieved from sorts or line and utilize data in various ways (cost estimating, inspection effectiveness, new business product design, PFMEA, Lessons Learned, etc.
    • Plans and conducts the analysis, inspection, design, test, and/or integration to assure the quality of assigned product or component.
    • Performs quality engineering reviews of design documentation for compliance with stated requirements, including vendor quality manuals and company quality records.
    • Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes, (i.e., Minitab).
    • Reviews all purchased products or components and provides input to the decision of whether to accept the product and future purchases from the vendor with our SDE on corrective actions requested of our suppliers.
    • Documents data obtained during all quality assurance activities, consistent with company policies and procedures.
    • Develops new approaches to solve problems identified during quality assurance activities.
    • Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
    • Prepares reports to communicate involvement and results of quality assurance activities.
    • Prepares and presents technical and program information to team members and management.
    • Directs technical and administrative workers engaged in quality assurance activities.
    • Maintains a working knowledge of government and industry quality assurance codes and standards.
    • Negotiates with customer regarding quality acceptance of non-conforming materials when appropriate (obtain buy-offs on questionable rejects). Support Customer if OEM approval of non-conforming material is required (go in as a “team”)


    • Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
    • Design – Generates creative solutions; Translates concepts and information into images; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail.
    • Problem Solving – 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.
    • Project Management – Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities.
    • Technical Skills – Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
    • Customer Service – Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.
    • Interpersonal Skills – 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.
    • Oral Communication – Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification;
    • Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
    • Written Communication – 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.
    • Teamwork – 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.
    • Quality Management – Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
    • Business Acumen – Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals.
    • Cost Consciousness – Works within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue; Conserves organizational resources.
    • Ethics – Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
    • Organizational Support – Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
    • Judgment – 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.
    • Motivation – Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
    • Planning/Organizing – 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.
    • Professionalism – 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.
    • Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
    • Quantity – Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
    • Safety and Security – Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
    • Adaptability – 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.
    • Attendance/Punctuality – Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
    • Dependability – 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.
    • Initiative – 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.
    • Innovation – 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.
    • Should be proficient in Microsoft Office applications such as Microsoft Project, Excel, PowerPoint, Word and CAD applications. Internet usage of web-based customer sites is required.
    • Working knowledge of Plexus.
    • Ongoing instruction (CEs) to keep thought process “fresh.


    Education and Job Experience Requirements

    • Bachelor’s Degree in Engineering Technology (Quality Engineering a plus) or a related discipline, plus two years of relevant experience; or a combination of education and experience that enables performance in all aspects of the position. 


    Work Environment and Physical Demands

    • While performing the duties of this Job, the associate may be exposed to moving mechanical parts.
    • The employee is occasionally exposed to fumes or airborne particles.
    • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
    • Position requires the abilities to walk, sit, stand, lift and carry up to 50 pounds; ability to hear, understand and convey verbal communications of and to other personnel.


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