Easter Seals Jobs

Job Description:

Creation of Validation protocols/reports and Validation Master plan

· Usage of current documentation from US for preparation of local documents

· Support of calibration systems (introduction of new, recalibration current gauges and excluding non-functional

gauges.

· Support detailed investigations of non-conforming product and customer inquiries, determine root causes, and

monitor the effectiveness of implemented corrective actions.

· Supports the QMS Manager with the collection and analysis of data and Internal and External Quality Key Indicators

(Customer Complaints, Internal Rejections, Internal Audits, Training, etc.) to determine the need to create new

Corrective and/or Preventive Actions.

· Assist in implementing quality and regulatory requirements (e.g., FDA, ISO 13485, QSR, cGMP), and ensure

compliance with testing SOPs and specifications Drive continuous improvement initiatives through direct reports and

by participating in cross-functional continuous improvement initiatives.

· Support preparation, review and revise, as required, DC-MP, SOPs, WI and specifications.

· Support preparation, monthly KPI reports and distributes them both internally and externally as needed.

· Performs other related duties as requested or assigned.

Job Requirements:

· Secondary mechanical, chemical or electrical engineering school

· Bachelor’s degree in Technical, Chemistry, Science or QMS preferred with 2-3 years of Quality experience

· Experience with creation of validation documentation.

· Compliance with medical devices

· Quality improvement

· Experience with calibration system.

Operating Company:

Spark

The Spark™ Clear Aligner System is manufactured by Ormco™, a global leader in innovative orthodontics products. Spark aligners are made with TruGEN™, the latest innovation in clear aligner material. In the same way that Spark is designed to give orthodontists more control and flexibility, our careers are designed to give you more control and flexibility. Working at the intersection of technology and patient needs, you’ll be positioned to drive disruptive thinking and spark your career.

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.

Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care.

Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com .