Quality Assurance Specialist

Horsham, PA - USA

Yearly Salary: USD 68000 - 82000

Posted on: 19 days ago

Vacancies: 1 Vacancy

Job Summary

Annual Salary Range: $68000-$82000

Join Biocoat a global leader in developing manufacturing and applying hydrophilic coatings on medical devices. Our Quality team is looking for afull-timeQuality Assurance Specialist!

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Review approve and document batch records and release of product
Administration and of all QMS documentation
Document Control and Training SME and electronic QMS (e.g. Grand Avenue) administrator
Implement review and facilitate investigations including Corrective and Preventive Actions (CAPA)
Assist with and/or lead investigation and resolution of customer complaints
Assist in and/or lead the management of change controls/ECOs and associated activities
Lead Material Review Board meetings and facilitate material and documentation dispositions as needed
Communicate deficiencies and/or compliance issues to QA/RA management
Responsible for driving goals and initiatives for continuous improvement of procedures processes and systems
Compile data and report QMS metrics as required
Administer and deliver Quality Assurance training
Coordinate and perform audits (internal process) as required
Support and organize audit preparation and performance activities
Support testing and release activities for Quality Control (QC)

QUALIFICATIONS & REQUIREMENTS:

Bachelors degree in a Scientific or Life Science field or equivalent work experience
1-3 years experience in a Quality function under ISO 13485 experience with QMS documentation and Good Document Practices and/or internal/lead auditor experience preferred
External certification (CQA CQE RAC etc.) preferred or at a minimum a clear path to achievement through advanced degrees or training
Excellent technical writing skills with great proficiency in spelling grammar formatting and completeness of documentation
Analytical approach to problem solving; critical thinker
Prior experience with eQMS systems preferred
Proficiency with Microsoft Word Excel Outlook and PowerPoint
Ability to work proficiently and independently in a regulated manufacturing setting lab related experience a plus
Independent initiative-taker; able to complete assigned tasks in a timely manner with minimal day-to-day direction; keen diligence and ability to follow directions
Ability to effectively present and lead in formal one-on-one and group situations
Strong people skills and ability to work with others in a positive and collaborative manner
Organized with ability to identify and manage priorities; reliable follow-up and follow-through as needed
Ability to follow and adhere to all Safety guidelines and processes including PPE as required.

Physical Requirements
Physical Demands: Stooping turning bending squatting kneeling and the ability to lift to thirty pounds ability to reach to seven feet unassisted; constant/repetitive standing; requires normal correctable vision and hearing and the ability to accurately discern color as necessary to perform job functions.
This position may require regular and sustained laboratory time around chemicals which may be hazardous and may work within a Class 7 cleanroom for periods of time.

What Biocoat Offers:

Competitive salary eligible for a discretionary bonus
Benefits (medical with HSA component dental vision critical illness and accident insurance)
Life insurance short- and long-term disability paid by the company
Flexible Spending Accounts (FSAs)
401(k) plan with an immediate company match
Paid time off
Education Assistance Program
Rewards and Recognition Program
Parental Leave
Employee Assistance Program
Additional benefits such as the opportunity to leave early on Fridaysbusiness casual dress friendly work environment and fun company events.

Biocoat is anis an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race religion color national origin gender gender identity sexual orientation age status as a protected veteran status as a qualified individual with disability or any other protected characteristic under law.

Biocoat Human Resources leads recruitment and employment for Biocoat. Unsolicited resumes sent to Biocoat from recruiters do not constitute any type of relationship between the recruiter and Biocoat and do not obligate Biocoat to pay fees should we hire from those resumes. We ask those external recruiters and/or agencies not contact or present candidates directly to our hiring managers or employees.

Required Experience:

Senior IC

Annual Salary Range: $68000-$82000Join Biocoat a global leader in developing manufacturing and applying hydrophilic coatings on medical devices. Our Quality team is looking for afull-timeQuality Assurance Specialist!ESSENTIAL DUTIES AND RESPONSIBILITIES:Review approve and document batch records and ...

Review approve and document batch records and release of product
Administration and of all QMS documentation
Document Control and Training SME and electronic QMS (e.g. Grand Avenue) administrator
Implement review and facilitate investigations including Corrective and Preventive Actions (CAPA)
Assist with and/or lead investigation and resolution of customer complaints
Assist in and/or lead the management of change controls/ECOs and associated activities
Lead Material Review Board meetings and facilitate material and documentation dispositions as needed
Communicate deficiencies and/or compliance issues to QA/RA management
Responsible for driving goals and initiatives for continuous improvement of procedures processes and systems
Compile data and report QMS metrics as required
Administer and deliver Quality Assurance training
Coordinate and perform audits (internal process) as required
Support and organize audit preparation and performance activities
Support testing and release activities for Quality Control (QC)

QUALIFICATIONS & REQUIREMENTS:

Bachelors degree in a Scientific or Life Science field or equivalent work experience
1-3 years experience in a Quality function under ISO 13485 experience with QMS documentation and Good Document Practices and/or internal/lead auditor experience preferred
External certification (CQA CQE RAC etc.) preferred or at a minimum a clear path to achievement through advanced degrees or training
Excellent technical writing skills with great proficiency in spelling grammar formatting and completeness of documentation
Analytical approach to problem solving; critical thinker
Prior experience with eQMS systems preferred
Proficiency with Microsoft Word Excel Outlook and PowerPoint
Ability to work proficiently and independently in a regulated manufacturing setting lab related experience a plus
Independent initiative-taker; able to complete assigned tasks in a timely manner with minimal day-to-day direction; keen diligence and ability to follow directions
Ability to effectively present and lead in formal one-on-one and group situations
Strong people skills and ability to work with others in a positive and collaborative manner
Organized with ability to identify and manage priorities; reliable follow-up and follow-through as needed
Ability to follow and adhere to all Safety guidelines and processes including PPE as required.

Competitive salary eligible for a discretionary bonus
Benefits (medical with HSA component dental vision critical illness and accident insurance)
Life insurance short- and long-term disability paid by the company
Flexible Spending Accounts (FSAs)
401(k) plan with an immediate company match
Paid time off
Education Assistance Program
Rewards and Recognition Program
Parental Leave
Employee Assistance Program
Additional benefits such as the opportunity to leave early on Fridaysbusiness casual dress friendly work environment and fun company events.