Sr. Quality Engineer

Work Flexibility: Onsite

Basic Function:

• Responsible for developing, applying, revising, and maintaining quality standards for processing raw materials and/or components into partially finished and/or finished products.

Responsibilities:

• Continuously comply with all regulatory related requirements.
• Will conduct Internal and External audits.  May train others in Quality Assurance/GMP/FDA-QSR related topics.
• Design and/or implement methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment: Statistical process control, Incoming part/product inspection criteria, Automated testing, Functional gauging, Productivity improvements
• Stop further processing in the event of encountering non-conforming products condition.
• May design and/or specify inspection and testing mechanisms and equipment.
• Prepare documentation for inspection/testing procedures.
• May support vendor management issues: Problem solving, Auditing, Inspection techniques/equipment, Training.       
• May interact with suppliers either telephonically or in person to develop and standardize inspection methods and or techniques to ensure components compliance with specifications.
• May interact with customers either telephonically or in person to solve reliability issues and/or answer general product questions. Complaint investigation/problem solving, Customer training, Design improvements and Special Orders.
• May assist during new product development. Validation support for product, processes, packaging, software, and sterilization.
• Analyze reports and/or returned products and recommends corrective action.  Will conduct failure analysis of products and processes: Problem solving efforts, Reliability design improvements, Product failure trending, Training.
• May work from verbal and/or written instructions.
• Commit to the EHS policy.
• Work closely with Operations to resolve in-house and supplier quality problems using established problem solving methodologies (Root Cause Analysis, Mistake Proofing, etc)
• Actively participate and lead on new product development teams to support product and process design and development activities.
• Lead and participate in the development and improvement of the manufacturing processes for existing and new product.  Review and approve inspection plans, routers and product drawings.
• Lead in development, review and approval of process and equipment validation/qualifications.

Supervisory Responsibilities:

• May coordinate the activities of one or more Quality Control Inspectors and/or Technicians.
• May evaluate the performance of one or more Quality Control Inspectors and/or Technicians based on pre-established performance parameters.
• Serves as mentors to QA Engineers and/or Associated QA Engineers

Physical Requirements:

• Sedentary Work:  Exerting up to 10 lbs. of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, etc.  Generally involves sitting most of the time.
• Very good visual acuity.
• The ability to work with and inspect very small objects and/or tools and component parts.

Mental Requirements:

• Observe and note minute inconsistencies.
• Generate, follow, and explain detailed instructions and inspection procedures.
• Complete detailed documentation accurately.
• Communicate product and/or component part deficiencies to Engineer, subordinate, or supervisory personnel.
• Analyze and resolve non-routine product issues using independent judgement and inspection equipment.

Required Skills:

• Strong analytical skills and presentation skills
• Effective interpersonal skills
• Blueprint/engineering schematic reading and interpretation
• Basic inspection techniques
• Basic PC skills
• Bilingual (English and Spanish)

Required Experience:

• 5+ years experience in Quality Assurance Engineering or related functional area
• Knowledge of inspection methods in the design and production of electromechanical and/or mechanical equipment.

Required Education and Training:

• B.S. in engineering or engineering related discipline.
• Licensed Engineer (EIT or PE) desired
• Some Quality Assurance training desired

Travel Percentage: None

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.