Senior Staff Microbiologist at Stryker

Limerick, County Limerick, Ireland

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor degree in Microbiology or equivalent/related subject required, with 6 years Microbiology related experience
Minimum of 8 years in Quality/Regulatory Affairs environment
Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required
Lead auditor certification desirable
Thorough knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise (Microbiology)
Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously
Knowledge of trends in industry and reg standards
Competent in statistical and analysis techniques

Responsibilities

Provide technical input into the sterility compliance of Stryker's product in accordance with relevant regulatory requirements and standards for medical devices, at a multi-site/global level
Oversee and act as subject matter expert/technical lead in all areas of microbiology and ensuring sustained levels of sterility compliance
Oversight of environmental & utility monitoring, bioburden and endotoxin testing practices and procedures, creating alignment and standardization across multi-sites
Execution, review and approval of Gamma and Ethylene Oxide sterilization validations and re-qualifications in line with relevant BS EN ISO standards
Assessment of sterility supplier validation
Interpreting sampling and monitoring data, applying statistical and analysis techniques, to determine control and trending; identifies and initiates when to take action
Lead technical input to NC and CAPA resolution within the Microbiology group and across multiple business units/sites; strong competency in assessment of effectivity and resulting sterility compliance; review and approval of CAPA
Act as technical lead for microbiology in cross-functional groups including product and process issues, root causing, projects, initiatives and other business critical forums
Subject Matter Expert, audit and review of Supplier quality activities with critical vendors in area of microbiology
Continually identify opportunities for stabilization of trends, statistical control of processes to allow cost saving
Mentor and train team and cross-functional groups as required (induction, GMP etc.)
Subject matter expert to internal & external regulatory requirements (including but not limited to European RHQ, Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements)
Subject matter expert to multi-site/global procedures; contribute to the development, maintenance and improvements of the policies and procedures to align to best practices, benchmarking against industry leads and regulatory requirements; input/BPO to corporate documents
Coach, mentor and train other functions in area of sterility and monitoring
Support and ensure compliance of new products to sites’ sterility standards; ensure successful integration of products into validated processes
Oversight & approval of biocompatible assessments of components, materials and consumables used in the manufacture of Stryker product
Provide Technical Assessment for completion of Risk Assessment for SofHA in area of sterility and microbiology; assessment and approval of acceptance of resolution to quality issues including concession management
Demonstrate technical supervisory capabilities and lead projects to completion

Skills

Microbiology

Sterility Compliance

Environmental Monitoring

Utility Monitoring

Bioburden Testing

Endotoxin Testing

Gamma Sterilization

Ethylene Oxide Sterilization

ISO Standards

Statistical Analysis

CAPA Management

Supplier Validation

Audit Review

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Medical & prescription plans

Supplemental health benefits

Flexible Spending accounts

Employee Assistance Program

Short-term & long-term disability

Tuition reimbursement

401(k) plan

Employee Stock Purchase Plan

Risks

Integration challenges from acquisitions may strain Stryker's resources.

Rapid tech advancements risk obsolescence of Stryker's current products.

Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.

Entry into the peripheral vascular segment diversifies Stryker's market presence.

Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.

The orthopedic implants market growth benefits Stryker's expanding product line.

Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

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