At Coherent, Inc., we have harnessed the power of light to become the world's leading independent designer, manufacturer and supplier of high-powered precision electro-optical components and laser-based solutions for medical, scientific and commercial applications. And although that alone is impressive, what truly makes Coherent, Inc. unique is our work environment. It's a strong, stable work environment that values the individual and places a premium on teamwork. Couple that with tremendous growth potential and the only thing that'll will be growing faster than Coherent will be your career. With an incredible range of innovative medical, scientific and commercial lasers, Coherent, Inc. is home to the most talented professionals in the laser and optical industry. Come learn more about us. We're searching for others like ourselves to join the brightest team in the business.
Develops, evaluates, revises, and applies technical quality assurance
protocols/methods to inspect and test in-process raw materials, production equipment,
and finished products. Ensures activities and items are in compliance with both
company quality assurance standards and applicable government regulations.
Performs analysis and identifies trends in the inspection of finished products,
in-process materials and bulk raw materials, and recommends corrective actions
when necessary. Ensures that established manufacturing inspection, sampling and
statistical process control procedures are followed. May assure compliance to
in-house and/or external specifications and standards, such as GMPs and ISO
regulations. Evaluates and analyzes the efforts in organizing, documenting, and interpreting inspection support documents
Uses professional concepts; applies company policies and procedures to resolve
a variety of issues. Works on problems of moderate scope where analysis of
situations or data requires a review of a variety of factors. Exercises
judgment within defined procedures and practices to determine appropriate
action. Has internal and some external contacts. Normally receives general
instructions on routine work, detailed instructions on new projects or
Will provide Quality Systems support (Supplier Quality, Calibration,
CAPA, Change Control, and Quality Records)
• BS in engineering required
• 3-5 yrs experience as a Quality Engineer in medical device product
development or manufacturing.
• Expertise in 21 CFR Part 820, ISO 13485
• Develop quality assurance standards
• Define and track quality assurance metrics
• Strong knowledge of QA methodologies and tools
• Working knowledge of MS Windows
• Combination of experience and education. Medical device experience preferred.
• ASQ certification a plus.
• Intermediate knowledge of FDA Quality System Regulation 21 CFR Part 820.
• Good organizational, attention to detail and follow-through skills
• Excellent verbal communication and customer interface skills.
• Ability to interface with multiple groups in the organization.
• Experience and practical application of SPC, Lean Manufacturing,
Error-Proofing, ANOVA, DOE, FMEA, Sampling Plans and Gage R&R analysis
required. Security Clearance is a plus. Proficiency in Microsoft Word, Excel,
Power Point, and Visio software. ASQ certification a plus.
Strong analytical skills with a working knowledge of statistical quality
methods, sampling methodologies, and Design of Experiments
• Knowledgeable of FDA regulations, Quality System Regulations (QSR), and ISO
• Experience in Risk Management, FMEA's, and applying ISO 14971
• Track record of success and appropriate cultural fit
• Experience with medical device development and manufacturing
• Support and enforce company goals and objectives, policies and procedures,
Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO
• Develop and maintain process documentation including assembly procedures,
test procedures, routers, travelers, BOMs, process flows, and process FMEAs.
• Qualify and optimize processes and tooling via IQ/OQ/PQ, Gage R&R
Studies, Process Capability Studies and Designs of Experiments.
• Participate in the investigation of failures and formulation and
implementation of action plans for all internal corrective actions, audit
findings. Address WIP and Incoming MRB in a timely manner.