This role is responsible for managing quality support for manufacturing and servicing of manufactured products. The Sr. Manager, QA will coach manufacturing, servicing and quality personnel on GMP and SOP compliance and empower them to identify and escalate quality issues, to ensure overall quality of the product.
Essential Duties and Responsibilities include the following (other duties may be assigned):
- Drive quality and manufacturing improvements to assure that processes are in a state of control.
- Review and approve changes made to processes and validation/qualification protocols and reports
- Oversee quality engineers and develop team for continuous improvement.
- Oversee floor quality assurance team to meet business demand.
- Serve as SMEs on manufacturing process controls and Support Internal and External Audits as needed.
- Assist on QMS integration related activities.
- Work with internal customers and supplier quality to ensure that non-conformances, failure analysis reports and deviations are appropriately investigated, documented, reviewed and approved.
- Initiate and develop standards and methods for inspection, testing, and evaluation as necessary. Assure product compliance to specifications through implementation of inspection criteria, procedures and training.
- Establish and maintain quality metrics.
- Identify and lead projects and initiatives to improve the quality system.
- Coach and develop team members.
- Perform other related duties as assigned.
- Ability to travel 5% of the time.
- Bachelors degree in engineering (mechanical, industrial, chemical, electrical), or other technical discipline, or advanced degree in other disciplines, or equivalent experience preferred.
- Minimum of 6-9 years of quality engineering experience in FDA regulated medical device manufacturing environment(s).
- Proficiency in reading and interpreting mechanical drawings and GD&T.
- Knowledge of QSR, ISO 13485, MDSAP.
- Medical Device Auditor certification preferred.
- Self-directed Problem solver.
- Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
- Knowledge of quality/continuous improvement tools (SPC, Statistics, DOE, Six Sigma) preferred
- Good oral and written communication skills.
- Ability to write reports, data analysis, and business correspondence.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Ability to clearly and concisely convey project accomplishments, obstacles, issues and status to project team members.
- Ability to work with mathematical concepts such as probability and statistical inference.
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- Ability to use MS Excel to perform calculations and interpret results/data.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to read technical literature and documents and extract important concepts.
- Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies.