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Antylia Scientific · 1 month ago

Sr. Manager, Quality and Regulatory

Buffalo, NY

Full-time

Onsite

Senior Level

$130K/yr - $160K/yr

7+ years exp

Antylia Scientific is seeking a Senior Manager, Quality Assurance and Regulatory Affairs responsible for implementing and executing the Quality program for all products, raw materials, processes, and services. The role involves strategic leadership in ensuring compliance with quality standards and working closely with various departments to address quality-related issues.

BiotechnologyLife Science

H1B Sponsor Likely

Responsibilities

Provide strategic leadership for the Quality Assurance, Quality Control and Document Control departments to ensure all products, raw materials, processes and services meet the Company’s exceptionally high-quality standards

Ensure company compliance with accredited quality systems: 21 CFR part 820 and ISO 13485, and Canada, Japan, and Australia requirements as applicable

Continue to strategically evolve company quality system as well as transition system with revisions of standards

Acts as Management Representative and performs all duties and tasks associated with that designation

Lead company audits either by accreditation bodies or by customers

Work with the appropriate teams to ensure proper action is taken and that the steps are initiated to avoid repeat errors

Maintain documentation and revision level of quality documentation for all products or services

Maintain and communicate all quality data to department managers for problem identification, resolution, loss reporting

Report company quality data including complaints, nonconforming product, and corrective/preventive action activities

Review non-conformities (NCRs) for determining root cause, creating corrective actions, providing customer follow up and close NCRs within an acceptable timeframe

Perform problem-solving tests to develop corrective actions for quality issues and to initiate continuous improvement

Report Quality metrics and trends routinely to the company

Coordinate returns to vendors and ensure corrective actions are in place to prevent future defects

Performs other duties as assigned

Qualification

Quality AssuranceRegulatory ComplianceLean ManufacturingSix SigmaQuality CertificationsStatistical Data AnalysisMS OfficeCommunication SkillsProblem SolvingOrganizational Skills

Required

Bachelor's degree from an accredited higher learning institution, preferably in a Quality or Engineering related field; Advanced degree preferred

Experience in high volume manufacturing environment, preferably in light manufacturing

Minimum of 7-10 years' experience related to quality assurance, lean manufacturing, regulatory compliance, and/or Six Sigma manufacturing

Quality certifications desired but not required in one or more of the following: ASQ/CQE, CMQ/OE, Six Sigma (Green or Black Belt), or TQM

Hands-on approach to troubleshoot and resolve quality related issues

Detail and Quality focused with strong organization, persuasion and negotiation skills

Ability to present information and respond to questions from various levels within the organization

Proficient in the use of MS Office

Thrives in a fast-paced, collaborative environment, efficiently works under pressures, within deadlines or other time essential constraints

Excellent communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization

Strong work ethic and an ability to excel within a rapidly changing and growing organization

Benefits

Medical, Dental, Vision Insurance

Disability Insurance

Life Insurance

401(k) company match

Paid Time Off (15 days annually)

Paid Holiday time (10 company-designated days)

Tuition Assistance

Additional benefits available with company package

Company

Antylia Scientific

Antylia Scientific is a global leader in peristaltic and single use bioprocessing solutions and life sciences

Founded in 1955

Vernon Hills, Illinois, USA

1001-5000 employees

https://antylia.com

H1B Sponsorship

Antylia Scientific has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2022 (1)

2021 (1)