Quality Control Supervisor Conshohocken PA

HCRC consulting; Conshohocken (Montgomery County); On-site; USD 70,000 - 87,000; Full time

Job summary

A leading consulting company is seeking a Quality Control Supervisor in Conshohocken to lead the quality inspection team and oversee quality assurance processes in a regulated environment. The ideal candidate will have a strong background in medical devices and a proven track record in supervisory roles. Join a supportive team offering competitive pay and benefits.

Benefits

401(k)

Health insurance

Dental Insurance

Vision insurance

PTO

Qualifications

• Minimum of 3 years’ experience in an FDA or ISO regulated environment.
• A minimum of 3 years of supervisory experience.
• Must have medical device/biotech experience, quality background.

Responsibilities

• Lead the quality inspection team and coordinate quality control processes.
• Manage inbound processes and oversee returns.
• Ensure compliance with FDA regulations and industry standards.

Skills

Quality assurance

Regulatory compliance

Team management

Education

Bachelor’s degree in science, engineering, or relevant discipline

Job description

We are looking for a Quality control supervisory to join our team full time in Conshohocken PA. The Quality Control Supervisor leads the quality inspection team within our group. This position coordinates and performs quality control processes; executes sound quality policies to ensure safety and quality of products; and performs other related duties as required. Primary responsibilities will include managing the inbound process, overseeing returns within our company; temperature monitoring; looking for ways to improve processes, and identifying any gaps for inbound or returns and sharing that with leadership. Must have medical device/biotech experience; quality background (3 years of legitimate quality experience); previous supervisory or leadership experience; and distribution experience

Duties & Responsibilities:

• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, other regulations (as appropriate), and industry standards
• Author and revise procedures/controlled documents according to FDA, AATB, and other applicable regulations
• Support development of validation/qualification protocols and summary reports in accordance with regulatory requirements and industry best practices
• Assures adequate sampling plans, and inspection procedures are implemented
• Maintains quality indicators and respective reports/ presentations
• Assist with deviations, nonconformances, complaints, CAPAs, SCARs, and safety incidents and ensure timely completion of associated investigations
• Oversee incoming inspection of HCT/Ps and medical devices in accordance with standard operating procedures and regulatory/accrediting agency requirements
• Sort and segregate acceptable and unacceptable HCT/P products and/or medical devices
• Manage and oversee review of quality control records to include equipment cleaning, maintenance, environmental monitoring, and supply inspections
• Assist with training of processes and corrective actions relating to quality
• Oversees the product release to ensure that safe and effective product is distributed to customers. Responsible for approval or rejection of components,finished products, and documents to achieve this purpose
• Directs the activities of the Quality Control team
• Owner of process controls and non-conforming product
• Report to work in-person and start job duties on time for established shift
  
  

Requirements:

• A minimum of a bachelor’s degree in science, engineering, other relevant discipline; minimum of 3 years’ experience working in an FDA or ISO regulated environment; or equivalent combination of education and experience
• A minimum of 3 years of supervisory experience or equivalent
• Must have medical device/biotech experience; quality background (3 years of legitimate quality experience); previous supervisory or leadership experience; distribution experience (not general warehouse experience)
  
  

Schedule:

• Full time (Mon- Friday)
  
  

Salary:

• $70k - $87k annually (depending on experience)
  
  

Benefits:

• 401(k)
• Health insurance
• Dental Insurance
• Vision insurance
• PTO
  
  

Ready to join a growing, supportive team in an excellent working environment?We need a team player with a great attitude to do whatever needs to get done! We offer competitive pay with great benefits and the chance to grow with us!If you are interested, please contact us.We look forward to hearing from you.

HCRC Staffing

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