Associate Quality Manager at Stryker

Cork, County Cork, Ireland

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Degree in Engineering, Science discipline or equivalent. Business Management or MBA is an advantage
Minimum of 6 years experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or regulated manufacturing environment
Experience of successfully creating and managing a talented, engaged and performing team is advantageous
Ability to implement organisation and functional strategy
Ability to initiate and implement change with a demonstrated track record (at individual level or team level)
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, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, and other Six Sigma tools
Must be able to work in a team & individual environment, interacting effectively at all levels, and across all functions with ability to develop organisational relationship and build trust
Demonstrated ability to make timely and sound decisions, through effective approaches for choosing a course of action or developing appropriate solutions. Works with a sense of urgency always
The candidate must be highly organized and disciplined

Responsibilities

Lead a dedicated Quality Operations team for a site/area, providing direction in quality assurance within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes
Deliver the compliance and business objectives of the function, driving engagement and leading the quality team, while ensuring compliance to Stryker Corporate and GQO requirements, Quality System Regulations and standards
Lead Quality Engineering Team to provide support and technical guidance / direction to the operational and functional areas on site, fostering an environment of proactive and continuous improvement approach to Quality
Support and align with the site commitment to ensure the organisation’s conformance to producing products meeting or exceeding customer requirements and the relevant regulatory standards
Foster a positive employee relations environment by promoting open communication, engagement and development of team members. Promote a culture of inclusiveness, trust, flexibility and teamwork
Create a highly talented team by sourcing, hiring, and placing individuals in positions that play to their strengths and future potential
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
Participate in ensuring the site(s) maintains continued certification to all regulatory bodies. Play a lead role in all internal and external audit programmes such as Corporate, notified body & FDA audits
Ensure effective control of product/process deviations for all released product and for the implementation of effective corrective action when non-conformances arise. Assess product & patient risk
Support the planning pipeline of quality improvement activities including initiatives to increase product quality, NCR & CAPA resolution, reduce cost, decrease in-efficiencies and improve risk management
Oversight and responsibility to ensure site maintains adherence to Quality KPIs performance indicators, and takes timely action to address adverse trends and deviations. Continuously monitors and partakes in global forums to assess opportunities for improvement
Assist in developing and supports local and global strategies for the Quality Operations function

Skills

Key technologies and capabilities for this role

Quality AssuranceQuality EngineeringRegulatory ComplianceFDA AuditsContinuous ImprovementTeam LeadershipQuality System RegulationsInternal AuditsEmployee EngagementHiring

Questions & Answers

Common questions about this position

What qualifications and experience are required for the Associate Quality Manager role?

A degree in Engineering, Science discipline or equivalent is required, with Business Management or MBA as an advantage. Minimum of 6 years experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or regulated manufacturing environment is needed.

Is this position remote or onsite?

The position is onsite.

What is the employment type for this role?

This is a full-time position.

What does the company culture emphasize for this role?

The role promotes a positive employee relations environment by fostering open communication, engagement, development of team members, and a culture of inclusiveness, trust, flexibility, and teamwork.

What makes a strong candidate for the Associate Quality Manager position?

Strong candidates will have a degree in Engineering or Science, at least 6 years in regulated manufacturing like Medical or Pharmaceutical, and leadership experience in quality operations, audits, and continuous improvement.

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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