Osteogenics Quality Associate (On-Site Lubbock, TX)

Job Description:

JOB SUMMARY:

The Quality Associate provides quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, support business and customer needs, and comply with government regulations, industry and OpCo standards.

PRIMARY DUTIES & RESPONSIBILITIES:

• Review device batch records for accuracy and compliance to established specifications release product into finished goods inventory.
• Supports quality management when quality management system improvements are needed and help develop new procedures or update existing ones to prevent a potential issue or improve a process.
• Provides guidance to manufacturing staff on QMS policies and inspections.
• Responsible for supplier selection & auditing, material qualification, material inspection and test, performance monitoring and supplier development.
• Manage process and product non-conformances in line with company procedures.
• Conducts quality assurance tests to ensure product specifications are met.
• Reviews, investigates, resolves and reports on quality discrepancies.
• Develops, maintains, monitors, and audit quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards.
• Monitors, investigates, and reports on customer complaints.
• Obtains the necessary quality system certifications and licenses (e.g. ISO, CE) to support market release of new product development.
• Supports for audit and inspection preparation, resolution of audit and inspection findings.
• Interacts frequently with other functional areas and operating entities.

Job Requirements:

• High school diploma/Associate’s degree with equivalent experience in a similar role.
• 3+ years of experience working in a Quality position within an FDA regulated industry (ex: tissue banking, medical device, biologics or pharmaceutical industries.

PREFERRED QUALIFICATION:

• Bachelor’s degree in a Science, Business, or a Technical field preferred but not required.
• Prior experience with batch record reviews, managing non-conformances.
• Ability to monitor, investigate, and report on customer complaints.
• Prior experience working at a tissue bank or as an AATB Certified Tissue Bank Specialist preferred.
• ASQ Certified Quality Auditor certification.
• Six Sigma Certifications: Green Belt, Yellow Belt.

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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.

Operating Company:

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.