Ormco, headquartered in Brea, CA, is a global leader and innovator of orthodontic products and solutions designed to enhance the lives of our customers and their patients. For nearly 60 years, Ormco has partnered with the global orthodontic community to help create over 20 million smiles in over 130 countries. Our distinguished products range from twin brackets (Symetri™ Clear, Titanium Orthos™ and Mini Diamond™) to pioneering the self-ligating appliances with the Damon™ System (including Damon™ Q2 and Damon™ Clear 2). Our latest Spark™ Clear Aligner System is designed to meet the needs of the orthodontist with the TruGEN™ material and 3D Approver software, making a more comfortable and aesthetically pleasing aligner experience for patients. From personalized service to professional education programs and marketing support, Ormco is committed to helping orthodontists achieve their clinical and practice management objectives. For more information about Ormco, visit www.ormco.com

Job Description:

Under the direction of the Director of Quality, Sr. QMS Specialist is responsible for ensuring that core functions of Quality Assurance are consistently in compliance with regulatory requirements and corporate standards. This involves assuring quality standards (FDA, ISO, CMDCAS, MDD, MDR, MDSAP and Canadian Medical Device requirements) are with respect to such process as CAPA, and Internal Auditing. The Sr. QMS Specialist will provide quality assurance to ensure the integrity of products received and shipped out and customer needs, comply with government regulations, industry and OpCo standards. This individual be responsible for supplier selection & auditing, material qualification, material inspection and test, performance monitoring and supplier development. They may also manage process and product non-conformances in line with company procedures and conduct quality assurance tests to ensure product specifications are met. They may review, investigate, resolve and report on quality discrepancies as well as develop, maintain, monitor, and audit quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards. They will monitor, investigate, and report on customer complaints and obtain the necessary quality system certifications and licenses (e.g. ISO, CE) to support market release of new product development. They will lead audit and inspection preparation, resolution of audit and inspection findings and have frequent interaction with other functional areas and operating entities.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Ensures FDA QSR (GMP), FDA OTC, ISO 13485, MDD, CMDCAS, MDR, MDSAP and Canadian Medical Device and other regulatory and/or national and international standards as applicable are continuously met.
• Maintain quality systems in compliance with all applicable regulatory standards as above and other relevant requirements throughout the facility.
• Responsible for the evaluation and submission of Medical Device Reporting to FDA and all competent authorities related to Adverse Events and Recalls.
• Function as liaison with Ormco Regulatory Affairs as it relates to new product, MDR/vigilance reporting, product licensing/registrations and other regulatory or compliance issues.
• Responsible for the Corrective and Preventive Action Process including, managing the presentations for the CAPA Review Board (CRB).
• Identify and oversee Corrective and Preventive Action teams in response to concerns identified through complaints, nonconforming materials or other various concerned activities.
• Prepare such reports, trend analyses, memoranda and other communications for and on behalf of management which may be called for from time-to-time.
• Perform such tasks as may be required by management form time-to-time.

Job Requirements:

MINIMUM QUALIFICATIONS

• Bachelors of Science, Quality Management or similar degree is required
• 3-5 years’ experience working with an FDA (QSR) and ISO Quality System
• Knowledge of FDA Medical Device Regulations and Good Manufacturing Practices is required
• Knowledge of ISO 13485 quality programs & quality system guidelines is required
• Knowledge of Quality Assurance/Quality Management System; Master Control is a plus

PREFERRED QUALIFICATIONS

• Knowledge of FDA process validation guidelines is preferred
• Strong organization skills and follow through; problem solving capabilities
• Excellent verbal and written communication skills
• Ability to learn and utilize computer in standard business applications including electronic document control, word processing, spreadsheets and databases.

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Target Market Salary Range:

Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.

$85,800 – $100,200

Operating Company:

Ormco

Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.

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.