Quality Assurance Manager at Stryker

Belfast, Northern Ireland, United Kingdom

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelor’s Degree in Engineering, Science discipline or equivalent. Business Management or MBA is an advantage
Minimum of 8+ years experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or regulated manufacturing environment
Minimum of 4 years experience and a proven track record of successfully creating and managing a highly talented, engaged and performing team
Demonstrated leadership ability to develop and implement organisation and functional strategy
Initiates, sponsors and implements change with a demonstrated track record in QA Improvement
Expert working knowledge of regulatory requirements, standards and regulations, with experience of managing inspections/audits by the FDA and other bodies
Working knowledge of quality tools such as SPC / Process Control

Responsibilities

Leadership of a high performing quality team that provides direct support and technical guidance/direction to the operational and functional areas on site, fostering an environment of proactive and continuous improvement approach to Quality
Ensure that the organisation’s conformance and commitment to producing products meets or exceeds customer requirements and the relevant regulatory standards
Drive an environment of compliance within Stryker by working with all function managers and their support staff to define expected quality standards and the roles/responsibilities in the maintenance of these standards
Champion a positive employee environment by promoting open communication, engagement and development of team members. Promote a culture of trust, flexibility, teamwork and inclusiveness, ensuring all relevant Quality functions (e.g. Shared Services Quality, Supplier Quality) are included in decision making processes as part of continuous improvement, problem solving and projects
Select competent talent and support the development of their future potential. Ensure effective training and performance management of the teams
Ensure the site maintains continued certification to all regulatory bodies. Play a lead role in all internal and external audit programs such as Corporate, notified body & FDA audits
Ensure effective management and control of product/process deviations for all released product and for the implementation of effective corrective action when non-conformances arise. Manage product & patient risk
Develop a quality planning pipeline of quality improvement activities including initiatives to increase product quality, NC & CAPA resolution, reduce cost, decrease inefficiencies and improve risk management
Oversight and responsibility to ensure site maintains adherence to Quality KPIs performance indicators, and take timely action to address adverse trends and deviations. Continuously monitor and partake in global forums to assess opportunities for improvement
Foster strong collaboration on a global scale by participating in and leading cross functional and global process improvement initiatives
Have a strategic view in identifying global alignment and developing strategies for best in class practices and benchmark against industry leads and regulatory requirements for the Quality function

Skills

Key technologies and capabilities for this role

Quality AssuranceTeam LeadershipRegulatory ComplianceContinuous ImprovementPerformance ManagementTrainingProblem SolvingQuality Operations

Questions & Answers

Common questions about this position

Is this position remote or onsite?

This is an onsite position with no remote work flexibility mentioned.

What are the key responsibilities of the Quality Assurance Manager?

The role involves leading a high-performing quality team, ensuring compliance to regulatory standards, driving continuous improvement, managing audits and deviations, and fostering collaboration across functions and globally.

What is the team structure for this role?

The position is the leader of a dedicated Quality Operations team at the Stryker Belfast site, providing direct support and technical guidance to operational and functional areas.

What does the company culture look like for this position?

The culture promotes a positive employee environment with open communication, engagement, development, trust, flexibility, teamwork, and inclusiveness, while championing proactive continuous improvement.

What makes a strong candidate for this Quality Assurance Manager role?

Strong candidates will have leadership experience in quality operations, expertise in regulatory compliance and audits, skills in team development and performance management, and a strategic focus on continuous improvement and risk management.

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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