Women’s Health Nurse Practitioner (NP) / Physician Assistant (PA)

The Quality Engineer is primarily responsible for the application, troubleshooting, and maintenance of procedures and elements of the company quality system. The Quality Engineer is also responsible for coordinating, planning, and executing projects as defined by the Quality Manager.

• Ensures that all employees understand and follow policies and procedures with regard to the Quality System and or company as they apply.
• Ensures maintenance and improvement of the Quality System through routine system audits and corrective actions.
• Plans activities and coordinates with other company resources to ensure assigned projects are being completed on a timely basis.
• Coordinates with and assists the activities of inspection resources as needed with the Quality Supervisor and Quality Manager to ensure consistent reliable performance and timely response to internal and external needs.
• Develops and prepares Quality Plans, sampling, and inspection procedures for manufacturing processes, including PPAP submissions, Validation documentation, MSA and any other product specific requirements as defined.
• Participate in product design reviews with primary responsibility for print review with an emphasis on tolerances, GD&T and capability. Recommends appropriate sampling and inspection techniques.
• Works with inspection resources to develop appropriate inspection techniques and gaging to ensure accurate and repeatable results.
• Conducts process capability studies, design of experiments, gage R&R and other process, product, or equipment related studies as defined by the Quality Manager or site management.
• Participates in internal and external nonconformance analysis and resolution, including communication to internal and external contacts as required.

Additional Responsibilities:

• Carries out other general responsibilities as required by site management.
• May conduct supplier and or site audits as required.
• Participates in customer visits and acts as the company quality representative during complaint resolution internally or at customer sites as needed.
• Develops and analyzes statistical data and product specifications to determine conformance to customer specifications.
• Identifies new techniques, and technologies to be used in process control, inspection, and calibration to improve quality, reduce inspection time and measurement error, and increase product throughput.
• Preparation of automotive PPAP submissions. Coordinates annual layouts, first article reports, MSA (gage R&R), CPK studies, DOEs, reliability studies and other special analysis as needed.
• Participates in product design reviews, new product quotes, validation protocols, and evaluation of print GD&T for manufacturability.

Required Skills/Abilities:

• Knowledge of ISO9001, ISO13485 and IATF16949 standards including internal auditing.
• Background in Quality Engineering, Metrology, and GD&T.
• Knowledge of automated inspection equipment including Vision Systems with basic programming skills (desired).
• Ability to handle multiple tasks with various levels of priority. Must be able to coordinate the requirements of daily production, Engineering, and Sales & Marketing with inspection services to achieve timely response to needs.
• Strong communication skills. Must be able to present ideas, results, and requirements effectively throughout the organization on a timely basis.
• Strong skills in applied statistics, reliability, Design of Experiments, MSA (gage R&R) and project management.
• Must have computer skills capable of utilizing various software packages commonly used in project management, databases, SPC, word processing and data acquisition.
• Well organized with strong interpersonal skills.

Education and Experience:

• Associates Degree or Bachelor's Degree, preferably BS, BSE, BSME, with minimum of 3 years' experience in quality assurance or senior inspector position in a metal stamping, injection molding or related industry, or equivalent experience.
• Certified Quality Engineer, Manager or Auditor (desired). Actively continuing training through, courses and seminars (Desired).
• Knowledge in the areas of SPC, automotive PPAP submission, and MSA (gage R&R). Experience with Reach/RoHS and ISO14001 preferred.