QA Manager I - United States
Want to know company name or location? Company managed [?]
What you’ll be doing:
- The Quality Control Manager works with other staff to establish procedures and quality standards and monitors these against agreed targets within the instrument manufacturing plant.
- Works as a team to determine and clearly stipulate the standards that products must meet in order to ensure company and customer quality standards.
- Ensures that all employees, including Supervisors and Managers, understand the set standards of quality; therefore, making communication and productive work relationships between the Quality Control Manager and fellow employees crucial.
- The Quality Control manager is responsible for managing the quality testing function, the document control function, and the Quality Engineers.
- This person is a key member of the plant leadership team and interacts with manufacturing leaders and other leaders in the company.
- The QC Manager is responsible for reviewing customer feedback to determine whether quality standards are being met.
- In addition this person is responsible to initiate and implement quality improvement activities as appropriate to raise the performance of the company’s product lines and also proactive in pushing quality upstream to suppliers.
- This person will be an integral part of ensuring the Nor Cal instrument manufacturing site is prepared for FDA and ISO 13485 certification and audits.
- Responsible for managing the plants Corrective and Preventive Action program (CAPA), First Article Inspection (FAI) process and various other quality programs.
What you need for this role:
- Bachelor's degree in Engineering
- ASQ certification strongly perferred
- Ten + years' relevant experience with at least 3 years in a leadership role
- Experience in a high mix, low volume, discreet manfacturing enrivonment
- Experience operating in a regulated environment (FDA and ISO; GMP preferred)
- Demonstrated ablility to lead a team and also leading through influence
- Knowledge of GMP, Lean Six Sigma and good documentation practices
- Advanced oral and written communication skills
- Experience with FDA and ISO audits
- Strong analytical skills
- Experience with process flows, SOPs, forms and instructions to streamline working practices
What’s in it for you:
- Competitive pay and great benefits including medical, dental, vision, 401k and more
- Opportunities for growth and training
- Stability of a profitable 60+ year old company
- Great work environment
- Our company is a global leader providing a broad array of clinical diagnostics and life science research products.
- With a team of more than 7,800 employees and a global network of operations serving our customers, we help people live longer, healthier lives.