Quality Assurance Manager (On-site)

Located in beautiful Santa Rosa, CA, SMC, Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.

In the role of our site Quality Manager, you will be responsible for overseeing and ensuring the products and services consistently meet established quality standards by developing and implementing quality control procedures, conducting inspections, analyzing data, and collaborating with teams to identify and address quality issues, ultimately aiming to improve overall production processes and customer satisfaction.

Essential Job Duties and Responsibilities:

• Accomplishes quality assurance human resource objectives by recruiting, selecting, training, coaching, assigning, evaluating, and disciplining employees; Communicating job expectations, monitoring activities, ensuring requirements are being met, and enforcing policies and procedures.
• Achieves operational objectives by collecting, analyzing, and summarizing data and trends; contributing information and analysis to monthly reviews and department strategic plans; Prepare and complete action goals and plans, this in conjunction with operational and other peers; Identify and resolve problems, participate in audits, determine value added improvements, and implement change.
• Maintain and improve product quality by maintaining visibility of the key product quality drivers; Investigate and understand customer requirements and complaints; Collaborate with other members of the leadership team to align efforts in delivering a high level of customer satisfaction.
• Provide ownership and leadership in driving quality assurance to meet high standards for outgoing product quality. This includes maintaining visibility and collaboration with internal peers, external customers, and supplied material quality.
• Actively engage in the Design to Production transition through ensuring quality control plans and expectations are understood, robust, and achievable. Provide data and inspection services feedback on execution of quality controls plans to NPD team.
• Provide management updates of significant issues or developments identified during quality assurance activities and actions being taken to improve the situation.
• Ensure staff has basic GMP understanding and complies too policies and procedures.
• Ensure data is being collected and retained per company policies and procedures.
• Maintains a working knowledge of industry quality assurance codes and standards.
• Organize problem solving in the areas of scrap, process capability, etc.
• Conduct system and product audits.
• Other duties as assigned.
  
  

Leadership Competencies:

• Builds Effective Teams – Ability to build strong identity teams who can apply their diverse skills and perspectives to achieve common goals.
• Collaborates – Builds partnerships and works collaboratively with others to meet shared objectives.
• Drives Results – Consistently achieves results, even under tough circumstances.
• Ensures Accountability – Holds self and others accountable to meet commitments.
• Instills Trust – Gains the confidence and trust of others through honesty, integrity and authenticity.
• Manages Complexity – Ability to make sense of complex, high quantity, and sometimes contradictory information to effectively solve problems.
• Plans and Aligns – Plans and prioritizes work to meet commitments aligned with organizational goals.
  
  

Essential Qualifications:

• Bachelor’s Degree required.
• Strong mathematics skills, basic knowledge in statistics, and mechanically inclined along with good written and verbal skills.
• At least 5 years of experience in a quality function, including a minimum of 2 years as a Quality Assurance Manager or equivalent.
• Strong knowledge on ISO13485
• Strong training, communication and management skills.
• Manufacturing experience required.
  
  

Desirable Qualifications:

• Experience in a medical device (FDA 820) or Pharmaceutical (FDA 210/211) regulated industry a plus
• ASQ certification a plus; CQE, CQM, CQA
• Injection Molding experience a plus,
• Problem solving training a plus; Six-Sigma Black/Green Belt/Lean-Kaizen
  
  

ADA Requirements:

• Stand, walk, bend, squat, twist, reach or otherwise move frequently
• Occasional repetitive motion and grasping
• Occasional climbing to reach areas on machines or racks
• Lift, move or otherwise transfer up to30lbs. occasionally, >20. frequently
• Typically sits, grasps items or performs keyboarding for occasional operation of a computer
• Potential need to travel up to 10%
  
  

Annual Salary Range $115,000 - $146,300 DOE

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