Job Description

Job Description

Job Description

Job Summary:

The Quality Manager is responsible for the oversight of quality functions in compliance with the FDA Quality System Regulations (QSR's), ISO 9001, ISO 14001, ISO 45001, IATF 16949 standards, and company policies and procedures. The Quality Manager has strong communication skills at all levels and manages the quality engineering and quality inspection groups in all functional activities.

Role and Responsibilities:

The individual must be capable of working independently and in a team setting. Major responsibilities include:

• Manage resources within the quality engineering and inspection functions providing guidance with day-to-day operational aspects and managing time and attendance through ADP.
• Provide leadership and support to quality engineering for planning, executing, and finalizing projects, defining objectives, and assuring deliverables are accurate and completed according to strict deadlines and within budget.
• Provides leadership and support to quality control functions providing guidance with prioritizing receiving, pre-outsource, pre-inventory, in-process, and final inspections assuring quality and delivery to our customers to meet on time delivery.
• Assign responsibilities and effectively communicate project expectations to team members and stakeholders in a timely and clear fashion.
• Communicate management by objectives (MbO) and hold initial, mid-year, and final yearly reviews with direct reports and complete personal MbO's with evidence of completion.

• Prevention and mitigation of financial risks caused by non-conformities
• Effective and efficient BMS with competent BPE including regulated interfaces between all departments.
• Support Quality and Regulatory functions by assisting with establishing and following policies, procedures, and accountability measures that ensure regulatory compliance and continuous quality performance improvement.
• Lead the efforts for customer communication, receiving and understanding requirements and assuring compliance to customer expectations.
• Maintenance, monitoring, improvement and further development of the certified management systems.
• Partner with Operations and Engineering to assure alignment of goals, objectives and strategies.
• Mentor team members in all quality disciplines to improve and strengthen the quality team.
• Identify quality engineering and inspection metrics; analyze and report trends to management.
• Assist in CAPA and continuous improvement activities.
• Promotion of continuous quality awareness in alignment with the company objectives and the SFS group Quality Policy (F-00028).
• Management of the BMS (P-00031) ensuring high degree of BMS maturity.
• Process owner and consultant specialist of assigned BMS documents.
• Aid with internal and customer audits, and regulatory agency inspections as applicable.
• Ensure completeness and adequacy of Tegra Medical documentation and records.
• Support and conduct Mid-term planning, and annual budget.
• Define QIP and KPI goals.
• Further or additional duties according to the need of the respective site.

Qualifications

• Quality management experience in the medical device industry, a plus.
• High understanding of the FDA Quality System Regulation.
• Ability to analyze operation and provide cost effective suggestions and targets to lower inspection costs.
• High technical aptitude.
• Good interpersonal and leadership skills.
• Growth mindset, attention to detail and excellent work ethic.
• Experience with Microsoft Project, Microsoft Office, Job Boss, Solid Works and other relevant software systems.
• Positive attitude, team player.
• Excellent written and verbal communication skills.

Education Requirements:

Bachelor's Degree with a minimum of 5 years of experience in the medical device industry or 8+ years of experience in an engineering and/or quality discipline role.

Physical Requirements:

• Frequently performing repetitive work.
• Occasional lifting (max. 40 lbs.)
• Occasional carrying (max. 40 lbs.)
• Subject to physical hazards from moving equipment and machine parts
• Constant safety glasses
• Constant full PPE
• Frequent standing
• Occasionally sitting, walking, pushing, pulling, reaching.

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