Supervisor of Quality Assurance

CMS

At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

ZOLL Cardiac Management Solutions offers a unique portfolio of novel technologies designed to deliver better insights and better outcomes. On any given day, clinicians utilize these ZOLL products for tens of thousands of cardiac patients around the world:

• LifeVest, the world's first wearable defibrillator, has been trusted to protect more than 1M patients at risk of sudden cardiac death.
• HFMS (Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been shown to reduce heart failure readmissions rates by 38 percent.
• TherOx Super Saturated Oxygen (SSO2) Therapy is the first FDA-approved therapy since the stent 20+ years ago to reduce infarct size in patients with the most severe heart attacks.

Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need.

ZOLL has been Pittsburgh's Manufacturer of the Year, one of Western PA's Healthiest Employers, and even one of Pittsburgh's Coolest Offices. But it's our unique opportunity to impact people's lives that makes ZOLL the ideal place to build your career.

Job Summary

The primary function of the Quality Assurance Supervisor is to ensure that all established quality system procedures are in place and executed in meeting the new build and service plans as well as departmental operational metrics. This will involve daily supervision of Quality Assurance Inspection Staff including but not limited to scheduling, training, interviewing, and all other tasks related to employee relations

Essential Functions

• Execute the build plan to meet field requirements.
• Execute the service plan to meet field requirements.
• Execute to meet departmental operational metrics.
• Direct supervision of quality assurance inspectors.
• Plan, assign, participate, supervise and review the work and work instructions and identify process improvement opportunities that drive quality and business results (i.​e.​ waste elimination, improving inspection efficiencies, adequate controls, etc.​).​
• Participate in the selection of inspectors; provide or coordinate training; work with employees to correct deficiencies; implement coaching and performance management; maintain records and prepare reports; ensure quality standards are met.​
• Ensure that proper inspection procedures are followed.​
• Work special high priority tasks as assigned.​
• Anticipate problems and work to mitigate risks.​

Required/Preferred Education and Experience

• Bachelor's Degree or Associate's Degree in a related field with training in a mechanical or electronics discipline required.
• 5-7 years related work experience required.
• Minimum five years of experience as a lead inspector or supervisor in an FDA regulated medical device manufacturing environment required.
• Must have a strong understanding of ISO 13485 and FDA GMPs required.
• Experience with database queries and reporting in SQL or Microsoft Access preferred.
• Lean experience preferred.

Knowledge, Skills and Abilities

• Excellent communication and organizational skills.

Physical Demands

• While performing the duties of this Job, the employee is regularly required to sit, talk and hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds.

Working Conditions

• This position is generally performed in a typical office environment that is usually quiet. Employee is expected to work collaboratively with team members, as well as able to work independently with limited supervision. Work will require significant computer and telephone work.

ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

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The annual salary for this position is:

$85,000.00 to $105,000.00

Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.

Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee’s primary work location.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran.

ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.