Sr. QMS Specialist - Hybrid

Job Description:

Under the direction of the Senior QA Manager, this position 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. 

Job Requirements:

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Other duties may be assigned, in addition to those identified below
• 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.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Knowledge of FDA Medical Device Regulations
• Knowledge of FDA process validation guidelines
• Knowledge of Current Good Manufacturing Practices
• Knowledge of ISO 13485 quality programs & Quality System Guidelines
• Knowledge of Quality Assurance/Quality Management Systems
• Abilities and skills in management & organization
• 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.
• Must be knowledgeable in the proper handling of chemicals and waste, both hazardous and nonhazardous, as defined by FDA, OSHA, EPA and DOT.

EDUCATION and EXPERIENCE

• Bachelor Degree or equivalent in Science Discipline or Quality Management
• 3-5 years experience working with an FDA (QSR) and ISO Quality System

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is frequently required to sit. The employee is occasionally required to stand and walk. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this Job, the employee is regularly required to sit. The employee is frequently required to walk. The employee is occasionally required to stand. The employee must occasionally lift and/or move up to 10 pounds.
• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

#LI-KC1

IND123

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.

$80,000 - $120,000

Operating Company:

Ormco

Ormco is a global leader and innovator of high-quality orthodontic products and solutions, including brackets and wires. For more than 60 years, our team has partnered with the orthodontic community to help create over 20 million smiles in more than 140 countries. We build trusted relationships. Each one is rooted in respect and understanding. We take that approach when we help orthodontists achieve their clinical and practice management objectives. We take the same approach when we help our team bring their personal best to work each day, ready to make a difference and reach their full potential.

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.