Envista

Senior Quality Assurance Specialist

United States of America, California, Yorba Linda · Senior

Sponsorship not specified$81k-$99kDetected 16 days ago

ComplianceExcelSAPERPRecruitingHRMedical DevicesCommunicationCollaborationProblem SolvingOrganizational SkillsMicrosoft Office

About the role

Proactive Problem Solving and Continuous Improvement - The role requires not only executing defined tasks but also questioning and improving processes.
Effective Collaboration and Communication - Coordinating with cross-functional teams (Quality, Regulatory, Engineering) and facilitating clear communication ensures smooth change implementation and stakeholder alignment.
KEY CHALLENGES: Navigating Regulatory and Process Complexity: - The regulatory landscape is continuously changing, with new standards and emerging interpretations.

Ensure documents are created and maintained according to QMS procedures
Provide support to create procedures and records
Track status of ECOs and associated documents within the Document Management System (SAP DMS)
Support supplier changes documentation and review
Support /perform supplier audits
Support the Senior Quality Assurance Manager in the preparation of internal and external audits (QMS and MAPPS audits)
Support the Senior Quality Assurance Manager in any follow-up actions resulting from audits (eg. CAPA).
Perform additional tasks as requested by the manager.
The Senior Quality Assurance Specialist is responsible for document control and change control in the Yorba Linda site.
In addition they shall provide support supplier quality assurance (supplier changes, issue quality notifications and SCARs) as well as support internal and external audits.

2+ years of related experience in a regulated industry
Knowledge MS Office applications, Word, Excel, Outlook
Specifically extended knowledge of MS Word
Knowledge of ISO 13485 and 21 CFR 820.
Fluent in speaking and writing English is required
The ability to ensure documentation meet compliance requirements is essential for audit readiness and risk mitigation.
preferably in MedTech/Pharma
ERP experience
SAP is a plus
Knowledge of Document Management Systems / Record keeping / Good Documentation Practice
Good administrative and communication skills
Good organizational skills
Accurate and detailed oriented in the day-to-day job
Mastery of Regulatory Compliance

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.
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.
$80,600 - $98,500

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 not pay a fee to any Agency that does not have such agreement and written approval in place.
Nobel Biocare
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.
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.

This listing is sourced directly from Envista's careers page and normalized into a canonical job model.