Job: Senior Quality Engineer

Primary responsibilities include providing support for New Product Development and Manufacturing processes and for improving the performance of the overall Quality System. Specific activities for this position include: establishing quality standards, statistical methods, test methods, process control techniques, and reviewing Quality System metrics to identified needed improvements. This position also supports the development of Production work instructions, Quality Assurance specifications, QC inspection methods, change control systems and validation and verification studies aimed at ensuring product safety and efficacy.

ESSENTIAL DUTIES AND RESPONSIBILITIES
• Support the New Product Development program
• Establish Risk Management Program
• Support Design Verifications and Production Process Validations
• Perform Sterilization, Cleaning, and Shipping Validations
• Review Product Design Specifications, Drawings, and Change Requests
• Establish Procedures for Statistical Methods (DOE, Sampling, and ANOVA)

ADDITIONAL AREAS OF RESPONSIBILITY
• Evaluate product design quality throughout product lifecycle (from capturing marketing needs through post-market surveillance).
• Developing and implementing product / process improvements based on production, supplier, and customer/field metrics.
• Assist the Design and Manufacturing Engineering departments to verify that modifications to the manufacturing processes and/or product design do not adversely affect product suitability for its intended use.
• Establish statistical process controls to ensure product conformance to specification and favorable Production yield levels.
• Specify and design inspection/test methods, fixtures, and set-ups.
• Other duties as assigned.

SUPERVISORY RESPONSIBILITIES
Not Applicable

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.
• Understanding of FDA QSR Regulations (21 CFR Part 820)
• Medical Device Standard ISO 13485
• Risk Management Standard ISO 14971

QUALIFICATIONS (CONTINUED)
• Knowledge of Quality Tools – Problem Solving / FMEA / Reliability planning / Design Controls / Working knowledge statistical methods (Sampling Plans, SPC, DOE, Probability distributions
• Experience developing calibration and inspection methods and equipment.
• Familiarity with Quality information systems.
• Familiarity with machining and assembly processes
• Excellent communications skills with working knowledge of English, both verbal and written
• Ability to read, analyze, and interpret technical specifications and procedures, and legal documents.
• Ability to write reports, business correspondence, and procedures.
• Ability to effectively present information and respond to questions from managers, suppliers and customers.
• Ability to develop and maintain strong working relationships with internal and external customers and suppliers.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

EDUCATION and/or EXPERIENCE
Bachelor’s degree (BS or BA) from a four-year college or university; or equivalent experience. Minimum of 6+ years related experience and/ or training; or equivalent combination of education and experience. Experience should include medical device industry experience in Quality Assurance, design evaluation/ engineering and auditing.

CERTIFICATES, LICENSES, REGISTRATIONS
Six Sigma Black Belt and ASQ CQE (Certified Quality Engineer)

EXEMPTION
Exempt