Quality Engineer I

Nissha Medical Technologies is looking to hire a Quality Engineer in Norwalk OH!This position will provide Quality Engineering support to ensure compliance with the Quality System regulatory requirements and the business strategy of the company. Represents Quality as a team member to support new product development procurement manufacturing returns and servicing of products produced.

Job Duties

• Cross Functional Team member to support new product development procurement manufacturing and servicing processes representing Quality Engineering discipline.
  • Completes assigned Quality Engineering tasks to schedule.
  • Promotes awareness of Quality and Regulatory requirements.
  • Leads or participates in the development of process and procedure development/changes.
  • Applies statistical process control (SPC) methods to evaluate current processes and process changes.
  • Develops new approaches to solve problems identified as part of the team.
• Assist in the implementation compliance and maintenance of standards (e.g. FDA ISO13485) and Quality policies and procedures.
• Trains location personnel on all aspects of the Quality System and regulatory standards.
• Applies the requirements of the Quality System to processes products or services for the location.
  • Supports the manufacturing line to address quality issues and resolution.
  • Provides support to metrology and preventive maintenance programs.
  • Supports validation and verification strategy for new and existing products and processes as assigned.
  • Leads the development and maintenance of Master Validation Plans.
  • Participates in the CAPA process as required as an assignee or project team member.
  • Investigates escalated product complaints to root cause to ensure timely customer response and correction.
  • Monitors product and process performance metrics and acts upon trends (positive or negative).
  • Leads MRB as a team member to ensure proper disposition of nonconformances.
  • Authors collaborates and approves Quality System documentation including change orders DHF DMR DHR labels and labelling etc.
  • Conducts internal vendor and process audits to schedule.
  • Interfaces with suppliers to resolve Quality issues.
• Develops and drives measurable Quality improvements relating to products processes and services.
• All other essential related duties as required

Requirements

• Bachelors degree in Engineering discipline or equivalent.
• Three to five years related experience and/or training; preferably in the medical device industry related to process/quality engineering.
• Knowledge of basic mechanical testing and material properties.
• Knowledge of metrology.
• Requires background and familiarity with U.S. FDA QSR requirements including ISO 9001 MDD 93/42 ISOand Canadian Medic
• ASQ certifications in one or more of the following areas is preferred but not required:
• Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).
• Working knowledge of problem solving skills good statistical and analytical skills.
• Working knowledge of Problem Solving Tools (i.e. Process Mapping Histograms FMEA Risk Assessment Cause & Effect Diagrams PDCA Pareto Analysis etc.)
• Working knowledge of Quality Tools (i.e. Quality Planning Quality Costs and Assessment Basic Statistics Advance Statistical Techniques Technical Writing Metrology & Calibration Inspection and Testing Sampling Principles and AQL TQM Lean Six Sigma etc.)
• Good verbal and written communication skills demonstrated by ability to generate technical reports and ability to make presentations to middle and upper management
• Proven Project Management skills.
• Proficient in the use of Information Technology and applications.

WORK ENVIRONMENT

• Chemicals/Solvents
• Clean Room Infectious
• Disease exposure

Why choose Nissha to build your career

At Nissha you can be assured that you will be part of a dynamic diverse team that is committed to bringing the best versions of ourselves each and every day. We recently received the General Excellence manufacturing award from Buffalo Business First which highlights our dedication to quality innovation and sustainability. This recognition celebrates the hard work of our team in producing highquality medical devices that meet industry standards and enhance patient care. If you are looking for meaningful work that motivates and inspires youve come to the right place!

What we offer that youll love

• Company Culture: At Nissha we pride ourselves on cultivating an atmosphere of teamwork where all associates feel heard and may not all think the same and we wouldnt have it any other way.
• Diversity & Inclusion: We are committed to equity racial justice and equal opportunity for all.
• Training and Development opportunities: Because we foster a culture of continuing education. Lets learn and grow together!
• Team Building Connection and Relationships: We support each other celebrate our achievements and milestones together and have FUN.
• Retirement: We know you want to retire comfortably and were here to help! Nissha offers a 401(k) Retirement Plan with an attractive employer contribution.
• Time Away from Work: Whether it is vacation or sick leave we all need time to recharge. Paid time off is an essential associate benefit and a pillar of selfcare.
• Engagement Activities: Recognition isnt just a onceayear occurrence at Nissha. We celebrate our team members yearround with summer picnics holiday parties and employee spotlight events just to name a few.
• Commitment to Wellness: We offer various opportunities to learn about your health be healthier and get rewarded for your healthy lifestyle by offering reduced medical premiums.