Lead technical supplier quality support for qualification, audits, validations, change assessments, and evaluation of supplier corrective action responses, while routine SCAR administration and supplier monitoring remain within Quality Systems.
Participate in regulatory, notified body, customer, corporate, and internal audits by providing technical documentation and evidence-based responses within the role’s areas of responsibility.
Partner with R&D, Manufacturing Engineering, Operations, Regulatory, Procurement, and Quality Systems to ensure quality requirements are appropriately incorporated and maintained throughout the product lifecycle.
Provide technical guidance to less experienced Quality Associates and support assigned departmental quality and continuous improvement initiatives.
Follow departmental Standard Operating Procedures, Work Instructions, and applicable safety requirements.
Incidental Duties: The above statements describe the general nature and level of work being performed. They are not intended to be an exhaustive list of all duties. Additional responsibilities may be assigned by management, as required.
Job Requirements
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily and function effectively in a fast-paced environment where priorities may change. The requirements below are representative of the knowledge, skill, and ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Education and Experience
Bachelor’s degree in Biomedical, Mechanical, Manufacturing, Industrial, Electrical, Chemical, Materials, or Systems Engineering, or a closely related engineering field.
Typically 2–5 years of quality experience in a regulated industry, preferably in medical devices.
Hands-on experience applying validation, design controls, risk management, investigations, CAPA, statistical methods, and quality system requirements in manufacturing.
Quality Engineer certification or another relevant professional certification preferred.
Required Skills and Abilities
Working knowledge of applicable medical device quality system requirements, ISO, GMP requirements, and relevant international standards.
Ability to independently interpret and apply regulatory, quality system, technical, and customer requirements and resolve complex quality issues using structured problem-solving.
Proficiency in statistical analysis and data interpretation, including practical applications of DOE, FMEA, capability analysis, and sampling methods.
Strong technical writing, project leadership, organization, and cross-functional communication skills.
Ability to understand product applications, specifications, functionality, assembly, manufacturing processes, and test methods.
Microsoft Office skills and the ability to quickly learn eQMS, ERP, and other business systems; experience with MasterControl, Oracle, or comparable systems preferred.
Ability to manage multiple priorities with minimal oversight, adapt to changing business needs, communicate effectively in English, and travel as required.
Physical Demands
Employee is required to sit at a desk for extended periods and frequently use hands and fingers.
Position requires occasional standing, walking, reaching, bending, and stooping.
The work environment has a moderate noise level. Safety glasses are required in production areas or as otherwise indicated.
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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.
For Field Sales roles, the salary range listed reflects base pay only and does not include incentive pay opportunities under the applicable sales compensation plan
$79,200 - $96,800
Operating Company
Orascoptic
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.
